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Abbott Laboratories, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 1915 Hurd Drive, Irving, TX, 75038
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EUDAMED SRN: —
FDA FEI Number: 3016438761
DUNS Number: —

Catalogue (584)

Page 1 of 12

Device	Model / Reference	Registries	Class	Status
Architect	4P57-19	FDA UDI	Class I	Unknown
Alinity	08P6301	FDA UDI	Class II	Active
Cell-Dyn	07H84-01	FDA UDI	Class I	Unknown
Alinity	01R0621	FDA UDI	Class I	Active
Accelerator	07L0102	FDA UDI	Class I	Active
Architect	3L43-02	FDA UDI	Class II	Active
Abbott Prism	7A03-30	FDA UDI	N	Unknown
Alinity-Architect	01P0603	FDA UDI	Class II	Active
Architect	06K5622	FDA UDI	Class I	Active
Alinity	01R1302	FDA UDI	Class I	Active
Architect	7D71-31	FDA UDI	Class I	Active
Architect	2K44-20	FDA UDI	Class I	Unknown
Alinity	09P6801	FDA UDI	Class II	Active
Architect	6K26-10	FDA UDI	Class II	Active
Architect	3L36-01	FDA UDI	Class II	Active
Alinity	08P5320	FDA UDI	Class II	Active
Architect	4J62-20	FDA UDI	Class I	Active
Alinity	09P6620	FDA UDI	U	Active
Architect	8K51-09	FDA UDI	Class I	Active
Architect	8K41-27	FDA UDI	Class I	Unknown
Architect	04P5726	FDA UDI	Class I	Active
Architect	1E64-02	FDA UDI	Class II	Active
Architect	8K28-35	FDA UDI	Class II	Active
Alinity	04R4701	FDA UDI	Class I	Active
Architect	1L75-25	FDA UDI	Class II	Active
Architect	2P32-50	FDA UDI	Class II	Active
Architect	3L41-01	FDA UDI	Class II	Active
Architect	4R29-3A	FDA UDI	Class I	Active
Architect	06R8601	FDA UDI	N	Active
Architect	6K53-21	FDA UDI	Class I	Active
Architect	06K4704	FDA UDI	Class I	Active
Architect	3L42-20	FDA UDI	Class II	Active
Architect	2K91-01	FDA UDI	Class II	Unknown
Architect	1P33-01	FDA UDI	Class II	Active
Architect	04T001A	FDA UDI	Class I	Active
Architect	1P34-01	FDA UDI	Class II	Active
Alinity	09P5402	FDA UDI	Class II	Active
Alinity	09P5802	FDA UDI	Class II	Active
Architect	4P55-15	FDA UDI	Class I	Unknown
Architect	2K44-10	FDA UDI	Class II	Unknown
Architect	08K5010	FDA UDI	Class I	Active
Abbott Prism	6D19-58	FDA UDI	N/A	Unknown
Abbott	7A12-60	FDA UDI	U	Unknown
Architect	1L86-01	FDA UDI	Class I	Active
Alinity	01R1421	FDA UDI	Class II	Active
Architect	8G98-20	FDA UDI	Class I	Active
Alinity	01R0821	FDA UDI	Class I	Active
Alinity	09P6502	FDA UDI	Class II	Active
Architect	3L43-04	FDA UDI	Class II	Active
Architect	6K31-10	FDA UDI	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 13, 2025	Z-0961-2026	—	open, classified	Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Sep 18, 2025	Z-0489-2026	—	open, classified	Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Mar 18, 2025	Z-1654-2025	—	open, classified	When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Mar 18, 2025	Z-1656-2025	—	open, classified	When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Mar 18, 2025	Z-1655-2025	—	open, classified	When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Mar 18, 2025	Z-1653-2025	—	open, classified	When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Mar 18, 2025	Z-1652-2025	—	open, classified	When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Jun 14, 2024	Z-2681-2024	—	open, classified	1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
Feb 21, 2024	Z-1476-2024	—	open, classified	The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
Oct 19, 2023	Z-0680-2024	—	open, classified	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Oct 19, 2023	Z-0681-2024	—	open, classified	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Oct 19, 2023	Z-0604-2024	—	open, classified	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Oct 19, 2023	Z-0682-2024	—	open, classified	The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
May 30, 2023	Z-0613-2024	—	open, classified	There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
Nov 24, 2022	Z-0958-2023	—	open, classified	Reaction vessels may contain a potential contaminant that could affect their optical performance.
Jul 26, 2022	Z-1660-2022	—	open, classified	One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
Jun 9, 2022	Z-1454-2022	—	open, classified	There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Jun 9, 2022	Z-1456-2022	—	open, classified	There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Jun 9, 2022	Z-1455-2022	—	open, classified	There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
Mar 8, 2022	Z-0891-2022	—	open, classified	This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
Feb 3, 2022	Z-0749-2022	—	open, classified	Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Sep 29, 2021	Z-0271-2022	—	open, classified	Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
Sep 29, 2021	Z-0272-2022	—	open, classified	Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
Jul 26, 2021	Z-2472-2021	—	open, classified	Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.
Jul 12, 2021	Z-2276-2021	—	open, classified	A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Jun 10, 2021	Z-2187-2021	—	open, classified	There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
Jun 10, 2021	Z-2185-2021	—	open, classified	There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
Jun 10, 2021	Z-2184-2021	—	open, classified	There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.
Jun 10, 2021	Z-2186-2021	—	open, classified	There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
Apr 2, 2020	Z-2251-2020	—	terminated	In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
Apr 1, 2020	Z-1894-2020	—	terminated	Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
Apr 1, 2020	Z-1893-2020	—	terminated	Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
Apr 1, 2020	Z-1895-2020	—	terminated	Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
May 24, 2019	Z-2078-2019	—	terminated	Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
May 24, 2019	Z-2079-2019	—	terminated	Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
May 22, 2019	Z-1688-2020	—	terminated	Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
May 9, 2019	Z-0173-2020	—	terminated	The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
May 1, 2019	Z-1671-2020	—	terminated	Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
Apr 9, 2019	Z-1361-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1357-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1358-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1362-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1355-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1359-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1360-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1363-2019	—	terminated	Devices were delivered without the required dry ice.
Apr 9, 2019	Z-1356-2019	—	terminated	Devices were delivered without the required dry ice.
Feb 20, 2019	Z-1074-2019	—	terminated	There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
Jan 2, 2019	Z-0971-2019	—	terminated	Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
Sep 7, 2018	Z-2755-2019	—	terminated	The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
Aug 28, 2018	Z-1296-2019	—	terminated	There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Jul 18, 2018	Z-1075-2019	—	terminated	The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Jul 18, 2018	Z-1076-2019	—	terminated	The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Jul 17, 2018	Z-1103-2019	—	terminated	There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Jul 17, 2018	Z-1102-2019	—	terminated	There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Jul 17, 2018	Z-1104-2019	—	terminated	There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
Jun 14, 2018	Z-2522-2018	—	terminated	Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
May 16, 2018	Z-1995-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1993-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1991-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1988-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1987-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1989-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1994-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1992-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 16, 2018	Z-1990-2019	—	terminated	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
Dec 8, 2017	Z-0922-2018	—	terminated	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
Dec 8, 2017	Z-0921-2018	—	terminated	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
Dec 8, 2017	Z-0923-2018	—	terminated	There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
Sep 29, 2017	Z-0165-2018	—	completed	The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Sep 29, 2017	Z-0166-2018	—	completed	The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Apr 18, 2017	Z-2613-2017	—	terminated	Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
Feb 13, 2017	Z-1438-2017	—	terminated	The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
Oct 11, 2016	Z-0379-2017	—	terminated	Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Mar 24, 2016	Z-1522-2016	—	terminated	Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
Mar 24, 2016	Z-1865-2016	—	terminated	Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Sep 9, 2015	Z-0163-2016	—	terminated	Incorrect tubing.
Jun 11, 2015	Z-2202-2015	—	terminated	The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
May 11, 2015	Z-1725-2015	—	terminated	The product is leaking from the cap and crystallization was noted as present around the cap.
Jan 15, 2015	Z-0011-2018	—	terminated	There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
Jul 22, 2014	Z-1932-2015	—	terminated	ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
Apr 30, 2014	Z-0135-2015	—	terminated	HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
Apr 7, 2014	Z-0131-2015	—	terminated	Package inserts have incorrect SmartWash parameters for Triglyceride.
Feb 12, 2014	Z-1671-2014	—	terminated	Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In
Feb 12, 2014	Z-1672-2014	—	terminated	Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. The issue may also impact your established ARCHITECT Intact PTH reference ranges. Abbott ARCHITECT In
Aug 12, 2013	Z-0020-2014	—	terminated	Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
Dec 18, 2012	Z-0987-2013	—	terminated	Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR
Dec 12, 2012	Z-0698-2013	—	terminated	The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.
Nov 16, 2012	Z-1118-2013	—	terminated	Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit
May 30, 2012	Z-1904-2012	—	terminated	The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.
Apr 11, 2012	Z-1509-2012	—	terminated	The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating.
Oct 7, 2011	Z-0162-2012	—	terminated	The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
Oct 3, 2011	Z-0189-2012	—	terminated	The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.
Aug 26, 2011	Z-3278-2011	—	terminated	The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.
Jul 11, 2011	Z-3031-2011	—	terminated	C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain patient samples and with non-Abbott Controls.
Apr 20, 2011	Z-2413-2011	—	terminated	The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.
Mar 15, 2011	Z-2017-2011	—	terminated	The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
Mar 15, 2011	Z-2020-2011	—	terminated	The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
Mar 15, 2011	Z-2015-2011	—	terminated	The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
Mar 15, 2011	Z-2018-2011	—	terminated	The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.