PlainRecalls

Bio-Rad Laboratories, Inc.

24 recalls on record · Latest: Sep 10, 2025

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Agency notice ledger

Federal filing book Bio-Rad Laboratories, Inc. MID-BOOK · SINGLE-AGENCY

#669 of 14,151 · 24 notices · 0.023% archive

  • BOOK 24 notices
  • RANK #669 of 14,151
  • SHARE 0.023% archive
  • AGENCY FDA Devices (24)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 10, 2025
  • PHOTO Bard Access Systems

Nearest notice-volume peer: Bard Access Systems (0 notice gap)

Bio-Rad Laboratories, Inc. accounts for about 0.023% of the 104,423-notice archive on 24 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Bio-Rad Laboratories, Inc. sits among 14,151 recalling firms

Bio-Rad Laboratories, Inc. ranks 669th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Bio-Rad Laboratories, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

24 669th of 14151 higher than 13,456 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Bio-Rad Laboratories, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Bio-Rad Laboratories, Inc. holds about 0.023% of archive notices alongside 24 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

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 calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

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 intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

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, REF: 663-1101

FDA Devices Moderate Sep 30, 2020

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-treponemal reagin antibodies in human serum or plasma.

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 clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

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 clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

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 measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.

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 Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.

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 hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.

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 EIA Kit contains an expiration date of 2016-04-30 in error.

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 diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.

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 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. 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 instrument cont

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-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.

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 precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM

Bio-Rad Laboratories, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Frequently Asked Questions

How many federal recall notices name Bio-Rad Laboratories, Inc.?
PlainRecalls indexes 24 distinct federal recall events naming Bio-Rad Laboratories, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Bio-Rad Laboratories, Inc. sit among other recalling firms?
Bio-Rad Laboratories, Inc. ranks #669 of 14,151 by distinct recall-event count among 14,151 firms in this archive (95th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Bio-Rad Laboratories, Inc.'s notices?
FDA Devices accounts for 24 of this firm's 24 indexed notices.
What product category dominates Bio-Rad Laboratories, Inc.'s filing book?
Filings for Bio-Rad Laboratories, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous?
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Bio-Rad Laboratories, Inc.: 24 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Bio-Rad Laboratories, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026