Bio-Rad Laboratories recalls

Bio-Rad Laboratories has 27 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 10 Sep 2025. 14 are still ongoing. The most frequent reason is potency & assay.

Total recalls27since 2012

Last 12 months0reported

Class I00% of total

Ongoing14latest 10 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 1 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 23 85%Class III 4 15%

Why bio-rad laboratories is recalled

Product types

By year

202514%
202414%
2023311%
2022519%
2021311%
202014%
2019311%
201814%
201627%
201514%

Ongoing bio-rad laboratories recalls

14 active

Reported	Class	Recall	Company	Reason	Where
10 Sep 2025Device	CLASS II	Platelia Toxo IgM recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	Nationwide
3 Apr 2024Device	CLASS II	Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled	Bio-Rad Laboratories	Other	Nationwide
17 May 2023Device	CLASS II	BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled	Bio-Rad Laboratories	Packaging Defects	Nationwide
19 Apr 2023Device	CLASS II	BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
19 Apr 2023Device	CLASS II	BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
7 Dec 2022Device	CLASS II	CMV IgM EIA, in vitro diagnostic recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	14 states

All bio-rad laboratories recalls, newest first

27 total

Reported	Class	Recall	Company	Reason	Where
10 Sep 2025Device	CLASS II	Platelia Toxo IgM recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	Nationwide
3 Apr 2024Device	CLASS II	Bio-Rad, REF: 12005660, QXDx Bcr-abl %IS Kit recalled	Bio-Rad Laboratories	Other	Nationwide
17 May 2023Device	CLASS II	BioPlex 2200 REF 665-2050, Apls IgM Pack, Apls IgM Reagent Pack recalled	Bio-Rad Laboratories	Packaging Defects	Nationwide
19 Apr 2023Device	CLASS II	BioPlex 2200, Anti-CCP Reagent Pack recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
19 Apr 2023Device	CLASS II	BioPlex 2200, Anti-CCP Calibrator Set recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
7 Dec 2022Device	CLASS II	CMV IgM EIA, in vitro diagnostic recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	14 states
8 Jun 2022Device	CLASS II	Resin Update Cd-rom recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Device Malfunction	24 states
25 May 2022Device	CLASS II	BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack recalled	Bio-Rad Laboratories	Other	Nationwide
23 Mar 2022Device	CLASS II	BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL recalled	Bio-Rad Laboratories	Potency & Assay	Nationwide
23 Mar 2022Device	CLASS II	BioPlex 2200 REF 12000650 Syph T Pack Syphilis Total & RPR Reagent recalled	Bio-Rad Laboratories	Potency & Assay	Nationwide
24 Nov 2021Device	CLASS II	Bio-rad BioPlex recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	Nationwide
24 Nov 2021Device	CLASS II	Bio-rad BioPlex recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	Nationwide
20 Oct 2021Device	CLASS II	BioPlex 2200 ANA Screen Control Set recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
30 Sep 2020Device	CLASS II	BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption recalled	Bio-Rad Laboratories	Potency & Assay	Nationwide
10 Jul 2019Device	CLASS II	Evolis Microplate System recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Device Malfunction	Nationwide
12 Jun 2019Device	CLASS II	MRSASelect II, IVD recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Packaging Defects	Nationwide
12 Jun 2019Device	CLASS II	MRSASelect, IVD recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Packaging Defects	Nationwide
1 Aug 2018Device	CLASS II	PR4100 Microplate Reader US recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Other	Nationwide
24 Feb 2016Device	CLASS II	Evolis Microplate System recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Device Malfunction	Nationwide
3 Feb 2016Device	CLASS II	D-10 Rack Loader recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Device Malfunction	Nationwide
1 Jul 2015Device	CLASS III	The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL recalled	Bio-Rad Laboratories	Other	5 states
14 May 2014Device	CLASS II	Variant II beta-thalassemia Short Program recalled	Bio-Rad Laboratories	Other	10 states
2 Apr 2014Device	CLASS II	D-10" Hemoglobin Testing System recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Device Malfunction	Nationwide
19 Feb 2014Device	CLASS III	D-10 Dual Program, which contains Update Kit D-10 A1c recalled	Bio-Rad Laboratories	Other	Nationwide
30 Oct 2013Device	CLASS III	FSE Image Upgrade Kit recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Device Malfunction	10 states
22 May 2013Device	CLASS III	Liquichek" ToRCH Plus IgM Control recalled by Bio-rad Laboratories	Bio-rad Laboratories	Potency & Assay	6 states
26 Sep 2012Device	CLASS II	The Bio-Rad Monolisa Anti-HBs EIA recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.