Biomerieux recalls

Biomerieux has 477 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 30 Sep 2026. 120 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls477since 2012

Last 12 months4reported

Class I184% of total

Ongoing120latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 18 4%Class II 451 95%Class III 8 2%

Why biomerieux is recalled

Product types

By year

202631%
202510%
202410%
20239520%
2022225%
202171%
202051%
201920%
2018245%
201721745%

Ongoing biomerieux recalls

120 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
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

All biomerieux recalls, newest first

477 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
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
11 Jan 2023Device	CLASS II	Etest Clinical Ceftolozane/tazo C/t Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Astute Reagent Astute Electronic Quality Ctrl Device Us recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vidas Clinical Vidas Brahms Procalcitonin 60t recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vidas Clinicalvidas Varicel recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vidas Clinical Vidas Measles Igg 60tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Etest Clinical Amoxi/clav 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vitek 2 Reagent Gp Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vitek 2 Reagent Yst Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vitek 2 Reagent Ast-gn95 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Previ Color Gram Reagent Iodine-b (na) recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Vitek Ms Clinical Reagent Vitek Ms-fa recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Etest Clinical Levofloxacin Le 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Etest Clinical Erythromycin Em 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Etest Clinical Fluconazole FL 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Bioball P.aeruginosa Nctc recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Etest Clinical Ertapenem Etp 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Ppm Lombard Products Ir&db - Tsa 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Ppm Lombard Products CT&ir&db-tsa + L & P80 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023Device	CLASS II	Astute Reagent Nephrocheck Liquid Controls Kit Us 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.