PlainRecalls

Bio-rad Laboratories, Inc.

Compiled from official public sources by the editorial team.

24 recalls on record · Latest: Sep 10, 2025

Bio-rad Laboratories, Inc. Recall Insight

Bio-rad Laboratories, Inc. appears on 24 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.024% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Sep 10, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 24 entries, severity tagging shows 0 critical, 21 moderate, and 3 lower-severity recalls. Affected-unit counts are disclosed on 24 of 24 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (24). The date window on this page runs from May 22, 2013 to Sep 10, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Sep 10, 2025

Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoass…

FDA Devices Moderate May 17, 2023

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

FDA Devices Moderate Apr 19, 2023

BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

FDA Devices Moderate Apr 19, 2023

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

FDA Devices Moderate Dec 7, 2022

CMV IgM EIA, in vitro diagnostic.

FDA Devices Moderate Jun 8, 2022

Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

FDA Devices Moderate May 25, 2022

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

FDA Devices Moderate Mar 23, 2022

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

FDA Devices Moderate Mar 23, 2022

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

FDA Devices Moderate Nov 24, 2021

BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the …

FDA Devices Moderate Nov 24, 2021

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…

FDA Devices Moderate Oct 20, 2021

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…

FDA Devices Moderate Sep 30, 2020

BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative …

FDA Devices Moderate Jul 10, 2019

EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

FDA Devices Moderate Jun 12, 2019

MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and c…

FDA Devices Moderate Jun 12, 2019

MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinica…

FDA Devices Moderate Aug 1, 2018

PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measureme…

FDA Devices Moderate Feb 24, 2016

EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microp…

FDA Devices Moderate Feb 3, 2016

D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemogl…

FDA Devices Low Jul 1, 2015

The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs…

FDA Devices Moderate May 14, 2014

Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnosti…

FDA Devices Moderate Apr 2, 2014

D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 9454…

FDA Devices Low Feb 19, 2014

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-…

FDA Devices Low May 22, 2013

Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.