Z-1742-2020Class II

The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical...

Name: Z-1742-2020 The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical...
Creator: Biomerieux Inc
Published: 2020-03-11
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2020-03-11 / Open, Classified

FDA source

Biomerieux Inc began a recall of 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... on 2020-03-11. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1742-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-11
Posted: 2020-04-17
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: N/A
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). .
FDA root cause: Under Investigation by firm
Action: On March, 11, 2020 a notification letter was issued to the impacted subsidiaries which included a Customer Letter to be translated into local language. The customer letter instructs the customer to stop the use of the impacted AST-P652 lot, to complete the attached Acknowledgement Form, and return any affected unused product to their local bioMrieux representative as soon as possible.
Quantity in commerce: 1698 cartons (15,940 cards)
Distribution: No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Product codes and lots: VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1742-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1742-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-17

Product code N/A

K053097Class IIVitek 2 Gram Positive Cefoxitin ScreenbioMerieux, Inc. / cleared 2005-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)