Bio-Rad Laboratories recalls
10 official recalls and safety alerts involving Bio-Rad Laboratories since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Bio-Rad Laboratories or the relevant agency.
- 2025-09-10
USBio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture…
Due to a risk of false positive results that could lead to unnecessary medical treatment.
FDA · DeviceBio-Rad Laboratories, Inc.U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.Official notice →- 2024-04-03
- US
Bio-Rad Laboratories recalls Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
FDA · DeviceBio-Rad LaboratoriesUS Nationwide distribution in the states of PA, SD, TX, FL, MN.Official notice → - 2023-05-17
- US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
FDA · DeviceBio-Rad Laboratories, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL,…Official notice → - 2023-04-19
- US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
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.…
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Czech…Official notice → - 2022-12-07
- US
Bio-Rad Laboratories, Inc. recalls CMV IgM EIA, in vitro diagnostic.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
FDA · DeviceBio-Rad Laboratories, Inc.U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: NoneOfficial notice → - 2022-06-08
- US
Bio-Rad Laboratories, Inc. recalls Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
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…
FDA · DeviceBio-Rad Laboratories, Inc.US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH,…Official notice → - 2022-05-25
- US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-03-23
- US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
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…
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution U.S. Nationwide distribution in the states of AK, AL,…Official notice → - 2021-11-24
- US
Bio-Rad Laboratories, Inc. recalls BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is…
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…
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA,…Official notice → - 2021-10-20
- US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen…
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.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S Nationwide distribution including in the states…Official notice →