CLASS II ONGOING Device recall · Reported 11 Jan 2023 · FDA Enforcement Report

Vitek Ms Clinical Reagent Vitek Ms-chca recalled by Biomerieux

Biomerieux is recalling Vitek Ms Clinical Reagent Vitek Ms-chca, distributed nationwide in the US. The recall was initiated on 9 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 03573026362836, Batch Numbers: 1009391190, 1009434380, 1009472100

Quantity recalled46 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0815-2023
FDA event ID: 91148
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Ongoing
Recall initiated: 9 Nov 2022
FDA classified: 4 Jan 2023
Reported: 11 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Test Kits & Diagnostics

Timeline

9 Nov 2022	Recall initiated by company
4 Jan 2023	Classified by FDA	+56 days
11 Jan 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Which lots are affected?

UDI/DI 03573026362836, Batch Numbers: 1009391190, 1009434380, 1009472100

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

93 other products · FDA event 91148

This product is part of a recall event; the main page for the event is Ppm Lombard Products Tsa 10plt recalled by Biomerieux.

Reported	Class	Recall	Company	Reason	Where
11 Jan 2023	CLASS II	Ppm Lombard Products Tsa 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Listeria 60t recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Hcg 60 Tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Industry Combourg Chromid Carba Us 20 Plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn80 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Amikacin Ak 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Rifampicin Ri 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-n801 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Bioball B.spizizenii Nctc recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Meropenem Mp 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Eravacycline Erv Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Colistin Co 256 Us B100 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Etest Meropenem/vaborbactam Mev Us S30 recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Rub Igg 60 Tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Clinical Craponne Chromid Vre 20 Plt Us recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api Listeria 10 Strips+10 Media recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Nh Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-xn09 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek Ms Clinical Reagent Vitek Ms-ds recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gp78 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products Irr Count-tact 3p Agar 100 Plt recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Etest Meropenem Mp M100 Us recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Clinical Chromid Mrsa 20 Plt Us recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Ceftazidim/avibactam Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn79 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Minocycline Mc 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Salmonella 60t recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products Tsa 3p W Neutralizers 100 Plt recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Tempo Reagents Tempo Control Kit recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api 20 C Aux 25 Strips+25 Media recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn81 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gp75 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products Tsa 3p W Neutralizers 100 Plt recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Clinical Craponne Clinical Chromid Candida 20 Plates recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products CT&ti-tsa + L & P80 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Gene-up Reagent Gene-up Salmonella recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Ceftriaxone Tx 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products R2a Medium 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Qcv-quality Control Vidas 60t recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Industry Combourg Lpt Broth (4x3l) recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Clinical Chromid Mrsa S Aureus 20plt Us recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Gene-up Reagent Gene-up Lysis Kit recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Imipenem Ip 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Previ Color Gram Reagent Nozzle Cleaning Solution (na) recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-st02 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn99 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api Nit1 Nit2 Reagents recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Bioball A.brasiliensis Ncpf recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Tobramycin Tm 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-xn15 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Clinical Chromid Strepto B Us 20 Plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Bioball K.rhizophila recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn70 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Vancomycin Va 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Bcl Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Clinical Craponne Chromid C.difficile 20 Plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Etest Vancomycin Va M100 Us recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gp67 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Imipenem Relebactam Ipr Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Estradiol Ii 60 Tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Industry Combourg Bacara 20plates recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api Vp1 Vp2 Reagents recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products T Phosphate Buffersterile 20x9ml recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api James 2amp recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Amoxi/clav 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn69 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Lh 60 Tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Benzylpenicil Pg 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Gn Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Astute Reagent Nephrocheck Liquid Controls Kit Us recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products CT&ir&db-tsa + L & P80 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Ppm Lombard Products Ir&db - Tsa 10plt recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Ertapenem Etp 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Bioball P.aeruginosa Nctc recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Fluconazole FL 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Erythromycin Em 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Levofloxacin Le 32 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek Ms Clinical Reagent Vitek Ms-fa recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Previ Color Gram Reagent Iodine-b (na) recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn95 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Yst Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Gp Test Kit Vtk2 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Amoxi/clav 256 Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Measles Igg 60tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinicalvidas Varicel recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Brahms Procalcitonin 60t recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Astute Reagent Astute Electronic Quality Ctrl Device Us recalled	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Etest Clinical Ceftolozane/tazo C/t Us S30 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vitek 2 Reagent Ast-gn73 Test Kit 20 Cards recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Dcount Systems Reagents Chemchrome V14 recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api 20 E 25 Strips recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Vidas Clinical Vidas Progesterone 60 Tests recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide
11 Jan 2023	CLASS II	Api Staph 25 Strips+25 Media recalled by Biomerieux	Biomerieux	Temperature Abuse	Nationwide

More recalls from Biomerieux

All 476

Reported	Class	Recall	Company	Reason	Where
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

Other Test Kits & Diagnostics recalls

All 2,656

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26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide