The Recall Desk

Manufacturer

Bio-Rad Laboratories, Inc.

24 recalls in our database name Bio-Rad Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
24
Critical
0
Severe
0
Most recent
2025-09-10

Of the 24 recalls from Bio-Rad Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–24 of 24

  • HighFDA (Devices)·Z-2515-2025·2025-09-10

    Toxoplasma IgM assay kits recalled over risk of false positive results

    Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.

    Product
    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2023·2023-05-17

    APLS IgM Diagnostic Reagent Packs Recalled Due to Incorrect Conjugate

    Bio-Rad Laboratories is recalling 932 BioPlex 2200 APLS IgM Reagent Packs (Lot 301538) nationwide because they were packaged with incorrect conjugate. This could result in false-positive and false-negative test results.

    Product
    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.

    Product
    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2023·2023-04-19

    BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity

    Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.

    Product
    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2023·2022-12-07

    CMV IgM EIA Diagnostic Test Recalled for Increased False Positives

    Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.

    Product
    CMV IgM EIA, in vitro diagnostic.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1208-2022·2022-06-08

    Bio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings

    Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.

    Product
    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1096-2022·2022-05-25

    BioPlex 2200 CMV IgM Reagent Pack Recalled for Variable Test Performance

    Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.

    Product
    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2022·2022-03-23

    BioPlex 2200 Syphilis Calibrator Set Recall Due to Vaccine Interference and Reagent Stability Issues

    Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.

    Product
    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2022·2022-03-23

    Syphilis Test Reagent Pack Recalled for Vaccine Interference and Manufacturing Defects

    Bio-Rad's BioPlex 2200 Syphilis Test Reagent Pack is being recalled due to concerns that COVID-19 vaccines may interfere with test results, and due to manufacturing defects affecting reagent stability.

    Product
    BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2022·2021-11-24

    Syphilis Test Reagent Pack Recalled Due to False Positive Results

    Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

    Product
    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or ti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2022·2021-11-24

    Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues

    Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.

    Product
    BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2022·2021-10-20

    Bio-Rad BioPlex 2200 ANA Screen Control lot incompatible with reagents

    Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.

    Product
    BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2982-2020·2020-09-30

    Bio-Rad Recalls BioPlex 2200 Syphilis Assay Due to Increased Reactivity

    Bio-Rad is recalling BioPlex 2200 Syphilis Total & RPR kits because of increased RPR reactivity levels in the kit material.

    Product
    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-trepo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1906-2019·2019-07-10

    Bio-Rad Recalls EVOLIS Microplate System Due to Software Error

    Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.

    Product
    EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2019·2019-06-12

    Bio-Rad Recalls MRSASelect II Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling MRSASelect II diagnostic plates due to abnormal agar coloration and non-characteristic colony growth. The recall covers 3,632 units distributed nationwide.

    Product
    MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1742-2019·2019-06-12

    Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.

    Product
    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2541-2018·2018-08-01

    Bio-Rad PR4100 Microplate Reader Recalled for Power Supply Connector Risk

    Bio-Rad is recalling 153 PR4100 Microplate Readers because the power supply connector can fit incompatible components, risking irreparable damage to the system.

    Product
    PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2016·2016-02-24

    Bio-Rad EVOLIS Microplate System Recalled for Plate Transport Hazard

    Bio-Rad is recalling 278 EVOLIS Microplate Systems because a low fluid alarm could cause the plate transport to continue running, pushing plates off the transporter.

    Product
    EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2016·2016-02-03

    Bio-Rad D-10 Rack Loader Recalled for Potential Sample ID Error

    Bio-Rad is recalling D-10 Rack Loaders because a rare configuration issue could assign patient results to incorrect sample IDs.

    Product
    D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1840-2015·2015-07-01

    Bio-Rad Anti-HBs Cutoff Calibrator Recalled for Incorrect Expiration Date

    Bio-Rad Laboratories is recalling 20 vials of Anti-HBs Cutoff Calibrator because the expiration date printed on the label is incorrect.

    Product
    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1537-2014·2014-05-14

    Bio-Rad Variant II beta-thalassemia Short Program kits recalled for buffer issues

    Bio-Rad is recalling Variant II beta-thalassemia Short Program kits because buffer issues may cause calibration and quality control failures.

    Product
    Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separatio
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1299-2014·2014-04-02

    Bio-Rad D-10 Hemoglobin Testing System Software Recall

    Bio-Rad is recalling D-10 Hemoglobin Testing Systems because the software may occasionally generate duplicate results with incorrect sample identifiers.

    Product
    D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0965-2014·2014-02-19

    Bio-Rad D-10 Hemoglobin Testing System Software Recall

    Bio-Rad is recalling D-10 Dual Program software due to incorrect cartridge count updates when switching programs.

    Product
    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1330-2013·2013-05-22

    Bio-Rad Recalls Liquichek ToRCH Plus IgM Control Due to HCV RNA

    Bio-Rad is recalling Liquichek ToRCH Plus IgM Control - Positive because it contains detectable levels of HCV RNA originating from the manufacturing process.

    Product
    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for us
    Category
    Medical Device
    Distribution
    6 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Bio-Rad Laboratories

American life science research firm

Country
United States
Founded
1952

Official website

Source: Wikidata (Q2904022), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.