Biomerieux recalls

Biomerieux has 476 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 15 Jul 2026. 119 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is lead & heavy metals.

Total recalls476since 2012

Last 12 months3reported

Class I184% of total

Ongoing119latest 15 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 1 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 18 4%Class II 450 95%Class III 8 2%

Why biomerieux is recalled

Product types

By year

202620%
202510%
202410%
20239520%
2022225%
202171%
202051%
201920%
2018245%
201721746%

Ongoing biomerieux recalls

119 active

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	Nationwide
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Lead & Heavy Metals	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Mold	Nationwide
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide
11 Jan 2023Device	CLASS II	Api Staph 25 Strips+25 Media recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide

All biomerieux recalls, newest first

476 total

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	Nationwide
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Lead & Heavy Metals	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Mold	Nationwide
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide
11 Jan 2023Device	CLASS II	Api Staph 25 Strips+25 Media recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vidas Clinical Vidas Progesterone 60 Tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Api 20 E 25 Strips recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Dcount Systems Reagents Chemchrome V14 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vitek 2 Reagent Ast-gn73 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	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.