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Bio-Rad Laboratories, Inc. FDA Recalls
11 recalls on file across devices, 0 of them Class I and 11 still open. Matched by name to BIO.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative iClass IIMay 30, 2025Due to a risk of false positive results that could lead to u |
| BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent PackClass IIFeb 28, 2023APLS IgM reagent kits were packaged with the incorrect conju |
| BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVDClass IIFeb 21, 2023Bio-Rad received four customer complaints from 11/30/2022 to |
| BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVDClass IIFeb 21, 2023Bio-Rad received four customer complaints from 11/30/2022 to |
| CMV IgM EIA, in vitro diagnostic.Class IIOct 19, 2022Due to an unusual increase in the positivity rate with human |
| BioPlex 2200 REF 12000670 ToRC IgM Reagent PackClass IIApr 14, 2022Performance concerns for the CMV IgM analyte. Analyte has d |
| Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000Class IIApr 7, 2022The problem is with the Bio-Rad VARIANT nbs Sickle Cell Prog |
| BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CALClass IIFeb 8, 2022Due to current concerns related to COVID-19 vaccine interfer |
| BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent PackClass IIFeb 8, 2022Due to current concerns related to COVID-19 vaccine interfer |
| BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR CalibrClass IISep 17, 2021Due to two issues: 1) Customer complaints associated with gr |
| BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit isClass IISep 17, 2021Due to two issues: 1) Customer complaints associated with gr |