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Bio-Rad Laboratories

Last updated September 17, 2026

Information

Country: US
Address: 9 Holland, Irvine, CA, 92618
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EUDAMED SRN: —
FDA FEI Number: 3010127294
DUNS Number: —

Catalogue (1180)

Page 1 of 24

Device	Model / Reference	Registries	Class	Status
Monolisa™	26154	FDA UDI	Class II	Active
Bio-Rad Laboratories, Inc.	25271	FDA UDI	Class II	Active
Monolisa™	26198	FDA UDI	Class II	Active
BioPlex 2200	6651360G	FDA UDI	Class I	Active
Kallestad	26107	FDA UDI	Class II	Active
Liquichek	649X	FDA UDI	Class I	Active
Autoimmune EIA	240DW	FDA UDI	Class II	Active
VARIANT II B-thalassemia	270-2154	FDA UDI	Class II	Active
Virotrol	00101F	FDA UDI	Class II	Active
Liquichek	267	FDA UDI	Class I	Active
D-10	220-0110	FDA UDI	Class II	Active
Variant Ii Turbo	270-2415	FDA UDI	Class II	Active
Liquichek	12011343	FDA UDI	Class II	Active
Kallestad ANCA	29413	FDA UDI	Class II	Active
Liquichek	466	FDA UDI	Class I	Active
VARIANT nbs Newborn Screening	250-3010	FDA UDI	Class II	Active
Liquichek	670X	FDA UDI	Class I	Active
Gs	32588	FDA UDI	Class II	Active
BioPlex 2200	SW4.1_V1	FDA UDI	Class I	Active
BioPlex 2200	SW4_V2	FDA UDI	Class II	Active
Lyphochek	323X	FDA UDI	Class I	Active
TOX/See	194-5203	FDA UDI	Class II	Active
InteliQ	12008292	FDA UDI	Class I	Active
Bio-Rad	25260	FDA UDI	Class II	Active
Bio-Rad	26181	FDA UDI	Class II	Active
BioPlex 2200	6633320	FDA UDI	Class II	Active
BioPlex 2200	SW4.1V1	FDA UDI	Class II	Active
96an	96AN-BPU-TRINITY	FDA UDI	Class II	Active
Liquichek	435	FDA UDI	Class I	Active
BioPlex 2200	6631920	FDA UDI	Class II	Active
Liquichek	444X	FDA UDI	Class I	Active
Gs	32591	FDA UDI	Class II	Active
BioPlex 2200	SW4.1_V2	FDA UDI	Class II	Active
BioPlex 2200	SW4.1V1	FDA UDI	Class II	Active
Liquichek	292X	FDA UDI	Class I	Active
AmpliClear	00127	FDA UDI	Class I	Active
Autoimmune EIA	96SA	FDA UDI	Class II	Active
Hemoglobin Variants System	250-0014	FDA UDI	Class I	Active
BioPlex 2200	6633800	FDA UDI	Class II	Unknown
Virotrol	00102C	FDA UDI	Class II	Active
Liquichek	27110	FDA UDI	Class I	Active
Liquichek	12003785	FDA UDI	Class I	Active
Lyphochek	406	FDA UDI	Class I	Active
BioPlex 2200	6632220	FDA UDI	Class II	Active
Kallestad ANCA	29401	FDA UDI	Class II	Active
InteliQ	12008310	FDA UDI	Class II	Active
TOX/See	194-5204	FDA UDI	Class II	Active
Liquichek	513	FDA UDI	Class I	Active
Lyphochek	500	FDA UDI	Class I	Active
BioPlex 2200	6632420	FDA UDI	Class II	Active

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FDA Recalls (91)

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
May 30, 2025	Z-2515-2025	—	open, classified	Due to a risk of false positive results that could lead to unnecessary medical treatment.
Feb 15, 2024	Z-1358-2024	—	open, classified	Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Feb 28, 2023	Z-1572-2023	—	open, classified	APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Feb 21, 2023	Z-1377-2023	—	open, classified	Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.
Feb 21, 2023	Z-1378-2023	—	open, classified	Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.
Oct 19, 2022	Z-0342-2023	—	open, classified	Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Apr 14, 2022	Z-1096-2022	—	open, classified	Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Apr 7, 2022	Z-1208-2022	—	open, classified	The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CDROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.
Feb 8, 2022	Z-0807-2022	—	open, classified	Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Feb 8, 2022	Z-0806-2022	—	open, classified	Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Sep 17, 2021	Z-0235-2022	—	open, classified	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Sep 17, 2021	Z-0236-2022	—	open, classified	Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
Apr 21, 2020	Z-2982-2020	—	open, classified	The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Nov 1, 2019	Z-0082-2022	—	terminated	A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Jan 10, 2019	Z-1906-2019	—	open, classified	User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
Jun 8, 2018	Z-1743-2019	—	terminated	Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Jun 8, 2018	Z-1742-2019	—	terminated	Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Apr 2, 2018	Z-2541-2018	—	terminated	The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
Dec 22, 2015	Z-0807-2016	—	terminated	The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
Dec 15, 2015	Z-0695-2016	—	terminated	On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.
May 13, 2015	Z-1840-2015	—	terminated	The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Apr 8, 2014	Z-1537-2014	—	terminated	There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
Feb 27, 2014	Z-1299-2014	—	terminated	On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
Nov 22, 2013	Z-0965-2014	—	terminated	D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
Aug 20, 2013	Z-0032-2014	—	terminated	The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
Apr 15, 2013	Z-1330-2013	—	terminated	The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product.
Jul 27, 2012	Z-2398-2012	—	terminated	Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.
Oct 25, 2011	Z-0399-2012	—	terminated	It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
Sep 12, 2011	Z-0026-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0020-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0023-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0024-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0027-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0021-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0025-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0019-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0018-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0017-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Sep 12, 2011	Z-0022-2012	—	terminated	A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Jul 28, 2011	Z-3159-2011	—	terminated	The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle.
Jul 11, 2011	Z-2889-2011	—	terminated	Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.
Mar 11, 2011	Z-2082-2011	—	terminated	Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704.
Jan 20, 2011	Z-1726-2011	—	terminated	Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate "INVALID".
Nov 23, 2010	Z-1650-2011	—	terminated	An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
Sep 7, 2010	Z-0109-2011	—	terminated	Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.
Jul 26, 2010	Z-0122-2011	—	terminated	Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.
Jul 19, 2010	Z-2201-2011	—	terminated	The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
Jun 30, 2010	Z-3051-2011	—	terminated	KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
Jun 24, 2010	Z-0612-2011	—	terminated	Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..
Apr 22, 2010	Z-1846-2011	—	terminated	The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.
Apr 14, 2010	Z-1984-2011	—	terminated	The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.
Mar 24, 2010	Z-1342-2011	—	terminated	The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
Mar 2, 2010	Z-1648-2011	—	terminated	The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
Mar 2, 2010	Z-1647-2011	—	terminated	The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits.
Mar 1, 2010	Z-0540-2011	—	terminated	The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
Mar 1, 2010	Z-1478-2011	—	terminated	Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
Mar 1, 2010	Z-0539-2011	—	terminated	The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.
Mar 1, 2010	Z-1479-2011	—	terminated	The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.
Feb 26, 2010	Z-0608-2011	—	terminated	The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.
Feb 24, 2010	Z-0613-2011	—	terminated	False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .
Feb 19, 2010	Z-1259-2011	—	terminated	The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results.
Jan 26, 2010	Z-1562-2011	—	terminated	Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.
Dec 8, 2009	Z-1898-2011	—	terminated	Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.
Dec 1, 2009	Z-1932-2011	—	terminated	Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.
Oct 12, 2009	Z-0867-2010	—	terminated	Product update kit CD rom will not upload. As a result, the device cannot be run.
Sep 29, 2009	Z-1495-2011	—	terminated	Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A.
Jul 14, 2009	Z-1145-2010	—	terminated	The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.
Jun 15, 2009	Z-1013-2010	—	terminated	Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
Jan 22, 2009	Z-1902-2010	—	terminated	Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
Jan 22, 2009	Z-1901-2010	—	terminated	Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
Dec 9, 2008	Z-1395-2009	—	terminated	The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
Oct 17, 2008	Z-1041-2009	—	terminated	Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
Aug 20, 2008	Z-0908-2010	—	terminated	Elevated optical density (OD) values with the kit Negative Control.
Aug 11, 2008	Z-1620-2010	—	terminated	The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay.
Jul 29, 2008	Z-2430-2008	—	terminated	The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Jul 29, 2008	Z-2429-2008	—	terminated	The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Jul 29, 2008	Z-2428-2008	—	terminated	The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
Mar 18, 2008	Z-1588-2008	—	terminated	Some product ROM cards have an incorrect program loaded and are unable to be updated.
Mar 18, 2008	Z-1589-2008	—	terminated	Some product ROM cards have an incorrect program loaded and are unable to be updated.
Jan 7, 2008	Z-1189-2008	—	terminated	Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.
Nov 13, 2007	Z-0575-2008	—	terminated	Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.
Nov 13, 2007	Z-1157-2008	—	terminated	False negative results due to reagent packs exhibiting low signal.
Nov 13, 2007	Z-1158-2008	—	terminated	False negative results due to reagent packs exhibiting low signal.
Nov 13, 2007	Z-1159-2008	—	terminated	False negative results due to reagent packs exhibiting low signal.
Nov 13, 2007	Z-1156-2008	—	terminated	False negative results due to reagent packs exhibiting low signal.
Sep 5, 2007	Z-0065-2008	—	terminated	Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
Feb 12, 2007	Z-0733-2007	—	terminated	The product may produce a faint line which could be interpreted as a false negative test result .
Nov 17, 2006	Z-0376-2007	—	terminated	The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
Jan 25, 2005	Z-0659-05	—	terminated	New instructions to recommend against using samples with visibly high level of blood.
Jun 4, 2004	Z-0289-06	—	terminated	The device was producing false negative results for cocaine tests.
Nov 6, 2003	Z-0348-04	—	terminated	Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.