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

Vitek 2 Reagent Ast-n801 Test Kit 20 Cards recalled by Biomerieux

Biomerieux is recalling Vitek 2 Reagent Ast-n801 Test Kit 20 Cards, 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 03573026618834, Batch Numbers: 412148504
Quantity recalled64 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-0856-2023
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

Timeline

9 Nov 2022Recall initiated by company
4 Jan 2023Classified by FDA+56 days
11 Jan 2023Published 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 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Vitek 2 Reagent Ast-n801 Test Kit 20 Cards recalled?

Yes. Biomerieux recalled Vitek 2 Reagent Ast-n801 Test Kit 20 Cards on 9 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0856-2023.

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 03573026618834, Batch Numbers: 412148504

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

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