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Abbott Point of Care Inc.

Last updated September 17, 2026

Information

Country: US
Address: 400 College Road East, Princeton, NJ, 08540
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2245578
DUNS Number: —

Catalogue (144)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
i-STAT	03P86-25	FDA UDI	Class II	Active
i-STAT	04P75-37	FDA UDI	Class II	Active
i-STAT	04X64-25	FDA UDI	Class II	Active
i-STAT	03P81-25	FDA UDI	Class II	Unknown
i-STAT	06P17-04	FDA UDI	Class I	Active
i-STAT PTplus Control Level 2	06P17-18	FDA UDI	Class II	Active
i-STAT	03P89-24	FDA UDI	Class II	Active
i-STAT G3+ Cartridge	03P78-26	FDA UDI	Class II	Active
i-STAT	04P75-33	FDA UDI	Class II	Active
i-STAT hs-TnI Control Level 1	06P17-21	FDA UDI	Class I	Active
i-STAT	03P75-58	FDA UDI	Class II	Active
i-STAT	06P17-08	FDA UDI	Class I	Active
i-STAT	04P75-34	FDA UDI	Class II	Active
i-STAT	03P78-25	FDA UDI	Class II	Active
i-STAT	03P90-25	FDA UDI	Class II	Active
i-STAT G Cartridge	03P83-26	FDA UDI	Class II	Active
i-STAT	04P75-38	FDA UDI	Class II	Active
i-STAT PTplus Cartridge	03P89-50	FDA UDI	Class II	Active
i-STAT TBI cartridge	03S09-25	FDA UDI	Class II	Active
i-STAT	04P75-32	FDA UDI	Class II	Active
i-STAT	06P17-26	FDA UDI	Class I	Active
i-STAT	02R29-01	FDA UDI	Class I	Active
i-STAT	06P17-03	FDA UDI	Class I	Active
i-STAT	03P77-25	FDA UDI	Class II	Active
i-STAT	03P75-87	FDA UDI	Class II	Active
i-STAT	06P17-12	FDA UDI	Class I	Active
i-STAT	06P17-01	FDA UDI	Class I	Active
i-STAT	03P75-56	FDA UDI	Class II	Active
i-STAT	06P17-10	FDA UDI	Class I	Active
i-STAT	05p58-25	FDA UDI	Class II	Active
i-STAT	04P75-45	FDA UDI	Class II	Active
i-STAT	03P75-60	FDA UDI	Class II	Active
i-STAT	03P87-25	FDA UDI	Class II	Active
i-STAT	04P75-35	FDA UDI	Class II	Active
i-STAT	06P17-11	FDA UDI	Class I	Active
i-STAT	03P75-07	FDA UDI	Class II	Active
i-STAT	06F12-14	FDA UDI	Class I	Active
i-STAT	03P84-25	FDA UDI	Class II	Active
i-STAT	04P75-40	FDA UDI	Class II	Active
i-STAT	03P75-52	FDA UDI	Class II	Active
i-STAT	02R29-02	FDA UDI	Class I	Active
i-STAT	05P73-01	FDA UDI	Class I	Active
i-STAT	04P75-42	FDA UDI	Class II	Active
i-STAT	03P85-51	FDA UDI	Class I	Active
i-STAT	03P79-25	FDA UDI	Class II	Active
i-STAT	03P75-84	FDA UDI	Class II	Active
i-STAT	04P75-30	FDA UDI	Class II	Active
i-STAT	03P92-25	FDA UDI	Class II	Active
i-STAT	03P75-55	FDA UDI	Class II	Active
i-STAT	03P75-61	FDA UDI	Class II	Active

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FDA Recalls (77)

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
Apr 1, 2026	Z-1999-2026	—	open, classified	Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Apr 1, 2026	Z-2000-2026	—	open, classified	Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Apr 1, 2026	Z-2001-2026	—	open, classified	Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Aug 21, 2025	Z-2585-2025	—	open, classified	Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Aug 21, 2025	Z-2582-2025	—	open, classified	Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Aug 21, 2025	Z-2584-2025	—	open, classified	Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Aug 21, 2025	Z-2583-2025	—	open, classified	Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Dec 22, 2020	Z-0880-2021	—	terminated	Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers 20100 to 20339 and 7 days for lot numbers 20340 and above Where = lot letter A, K, L, M, N, W or Y.
Dec 22, 2020	Z-0881-2021	—	terminated	Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers 20100 to 20339 and 7 days for lot numbers 20340 and above Where = lot letter A, K, L, M, N, W or Y.
Jan 15, 2020	Z-1262-2020	—	terminated	The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
Jan 15, 2020	Z-1263-2020	—	terminated	The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
Jan 14, 2020	Z-1265-2020	—	terminated	Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.
Oct 16, 2019	Z-0761-2020	—	terminated	i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Sep 13, 2018	Z-0615-2019	—	terminated	Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated
Sep 12, 2017	Z-0926-2018	—	terminated	Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.
Jun 15, 2015	Z-2361-2015	—	terminated	Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.
Jan 1, 2014	Z-1306-2014	—	terminated	Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
Oct 28, 2013	Z-0451-2014	—	terminated	Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
Jul 19, 2012	Z-0192-2013	—	terminated	Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials.
Mar 7, 2012	Z-2237-2012	—	terminated	Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
Mar 1, 2012	Z-2157-2012	—	terminated	The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Feb 1, 2012	Z-2169-2012	—	terminated	The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Feb 1, 2012	Z-2171-2012	—	terminated	The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Feb 1, 2012	Z-2170-2012	—	terminated	The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Sep 29, 2011	Z-0180-2012	—	terminated	i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed results.
Sep 8, 2011	Z-1978-2012	—	terminated	Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011	Z-1975-2012	—	terminated	Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011	Z-1977-2012	—	terminated	Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011	Z-1976-2012	—	terminated	Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011	Z-1973-2012	—	terminated	Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011	Z-1974-2012	—	terminated	Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Feb 15, 2011	Z-2022-2011	—	terminated	i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
Jan 1, 2011	Z-2133-2012	—	terminated	i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
Dec 17, 2010	Z-1864-2011	—	terminated	Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set.
Dec 17, 2010	Z-1863-2011	—	terminated	Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set.
Dec 3, 2010	Z-1341-2011	—	terminated	Celite ACT cartridges have increased numbers of values outside the accepted allowable error.
Oct 6, 2010	Z-0400-2011	—	terminated	Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
Oct 6, 2010	Z-0399-2011	—	terminated	Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
Sep 20, 2010	Z-0594-2011	—	terminated	i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Sep 20, 2010	Z-0597-2011	—	terminated	i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Sep 20, 2010	Z-0598-2011	—	terminated	i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Sep 20, 2010	Z-0595-2011	—	terminated	i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Sep 20, 2010	Z-0596-2011	—	terminated	i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Sep 20, 2010	Z-0593-2011	—	terminated	i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Aug 20, 2010	Z-2462-2010	—	terminated	Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
Aug 3, 2010	Z-0930-2011	—	terminated	Two cartridge lots were identified that may generate falsely elevated PCO2 results.
Aug 3, 2010	Z-1020-2011	—	terminated	Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.
Aug 3, 2010	Z-0929-2011	—	terminated	Two cartridge lots were identified that may generate falsely elevated PCO2 results.
May 5, 2010	Z-1996-2010	—	terminated	A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.
Mar 17, 2010	Z-0456-2011	—	terminated	The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
Feb 5, 2010	Z-1793-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1791-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1798-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1797-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1794-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1795-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1796-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Feb 5, 2010	Z-1792-2010	—	terminated	Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
Nov 6, 2009	Z-1133-2010	—	terminated	Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
Sep 29, 2009	Z-0865-2010	—	terminated	Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.
Sep 9, 2009	Z-0812-2010	—	terminated	The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
Aug 18, 2009	Z-0814-2010	—	terminated	Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.
Aug 18, 2009	Z-0813-2010	—	terminated	Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.
Apr 22, 2009	Z-2328-2009	—	terminated	It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
Feb 23, 2009	Z-1540-2009	—	terminated	Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
Feb 23, 2009	Z-1541-2009	—	terminated	Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
Jan 1, 2008	Z-0318-2011	—	terminated	i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
Jan 1, 2008	Z-0317-2011	—	terminated	i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
Jan 1, 2008	Z-0319-2011	—	terminated	i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.
Oct 18, 2007	Z-0374-2008	—	terminated	Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007	Z-0372-2008	—	terminated	Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007	Z-0373-2008	—	terminated	Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007	Z-0375-2008	—	terminated	Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007	Z-0370-2008	—	terminated	Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Oct 18, 2007	Z-0371-2008	—	terminated	Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Dec 12, 2006	Z-0364-2007	—	terminated	Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.
Sep 25, 2006	Z-1621-2011	—	terminated	Certain lots of G3+ cartridges may be difficult to fill.