Bio-Rad Laboratories, Inc. recalls
Every recall we track for Bio-Rad Laboratories, Inc. — 17 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Bio-Rad Laboratories, Inc. peaked in 2022 (5); 17 since 2017.
All FDA recall records for Bio-Rad Laboratories, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 3 | 0 | 3 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 1 | 1 | 2 |
| 2022 | 0 | 0 | 5 | 0 | 5 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Bio-Rad Laboratories, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Bio-Rad Laboratories, Inc. recalls
13 shown- Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative
Bio-Rad recalls Platelia Toxo IgM assay (Catalog 26211) due to potential false positive results causing unnecessary medical treatment. Affected units have UDI code 03610520005552.
Bio-RadMay 30, 2025 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Bio-Rad recalls BioPlex 2200 APLS IgM reagent kits with incorrect conjugate that may cause false positive or negative test results. Affected kits have specific lot codes and UDI-DI numbers.
Bio-RadFeb 28, 2023 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Bio-Rad recalls specific lot of BioPlex 2200 Anti-CCP Calibrator Set due to reduced specificity causing potential false positives in tests. Affected units have lot number 301481 and calibrator lot 53727. No immediate action required per recall.
Bio-RadFeb 21, 2023 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls CMV IgM EIA, in vitro diagnostic.
Bio-Rad recalls CMV IgM EIA diagnostic tests due to unusual increases in positivity rates with human IgM antibodies to cytomegalovirus. Affected lots may lead to inaccurate test results.
Bio-RadOct 19, 2022 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack due to inconsistent CMV IgM analyte results from variable background levels.
Bio-RadApr 14, 2022 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Bio-Rad recalls specific lots of VARIANT nbs Sickle Cell Program Resin Update CD-ROM (250-3020) that overwrite custom lab settings during updates, risking incorrect sample results. Affected units include certain reorder packs with specific lot numbers.
Bio-RadApr 7, 2022 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR Reagent Pack due to possible interference with COVID-19 vaccines. Affected units have specific lot numbers and catalog codes. No immediate action needed as the hazard is not active in normal use.
Bio-RadFeb 8, 2022 - UnratedMedical device
Bio-Rad Laboratories, Inc. recalls BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR
Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR Calibrator Set (12000651) due to potential false positive RPR results from COVID vaccinations and stability issues. Affected units may show incorrect syphilis test results.
Bio-RadSep 17, 2021 - Lower riskMedical device
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage:
Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR kit due to potential increased RPR reactivity in specific lots. Affected kits may produce inaccurate results for syphilis testing.
Bio-RadApr 21, 2020 - Lower riskMedical device
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;
Bio-Rad recalls BioPlex 2200 ANA Screen Control Sets (REF: 663-1131) that are incompatible with older ANA reagent packs and calibrators. Affected units may cause inaccurate test results.
Bio-RadNov 1, 2019 - Lower riskMedical device
Bio-Rad Laboratories, Inc recalls EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Bio-Rad recalls EVOLIS Microplate System with TimeLiner software due to potential for incorrect lab results. Affected units may need correction to prevent errors in laboratory testing.
Bio-RadJan 10, 2019 - Lower riskMedical device
Bio-Rad Laboratories, Inc recalls MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with
Bio-Rad recalls MRSASelect agar plates (lot numbers 64179161-64192125) due to abnormal coloration and non-characteristic MRSA colonies. Consumers should check their lot numbers and contact Bio-Rad for details.
Bio-RadJun 8, 2018 - Lower riskMedical device
Bio-Rad Laboratories Inc recalls PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well
Bio-Rad recalls PR4100 Microplate Readers with specific serial numbers due to power supply connector incompatibility that could cause system damage if incorrectly connected.
Bio-RadApr 2, 2018
Bio-Rad Laboratories, Inc. recall questions
How many recalls has Bio-Rad Laboratories, Inc. had?
17 recalls from Bio-Rad Laboratories, Inc. are on record with U.S. safety agencies, from 2018–2025.
What is the most recent Bio-Rad Laboratories, Inc. recall?
Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative, dated May 30, 2025. Every Bio-Rad Laboratories, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Bio-Rad Laboratories, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Bio-Rad Laboratories, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.