CLASS II ONGOING Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

The Vitek-positive Susceptibility Card is intended recalled

Biomerieux is recalling The Vitek-positive Susceptibility Card is intended for use with the Vitek 2 Systems in. The recall was initiated on 11 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021

Quantity recalled1698 cartons (15,940 cards)

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-1742-2020
FDA event ID: 85209
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Ongoing
Recall initiated: 11 Mar 2020
FDA classified: 17 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination
Device type: Other Medical Devices

Timeline

11 Mar 2020	Recall initiated by company
17 Apr 2020	Classified by FDA	+37 days
29 Apr 2020	Published in enforcement report	+12 days

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

Reason for recall

There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .

Product as listed by the FDA

The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

Where it was distributed

No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium

Questions about this recall

Why was it recalled?

There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .

Which lots are affected?

VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021

Where was it sold?

No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium

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.

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