Z-1013-2013Class II

bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to...

Name: Z-1013-2013 bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to...
Creator: Biomerieux Inc
Published: 2013-02-06
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-02-06 / Terminated / root cause: labeling and UDI

FDA source

Biomerieux Inc began a recall of bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to... on 2013-02-06. FDA classified it as Class II and gives the reason as "The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1013-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-06
Posted: 2013-03-27
Terminated: 2013-10-30
Recalling firm: bioMerieux, Inc.
Product: bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
Product code: LTW Susceptibility Test Cards, Antimicrobial
Reason for recall: The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.
Quantity in commerce: 4/20-card cartons
Distribution: Distributed only in HI.
Product codes and lots: lot number: 540274420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1013-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1013-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-27

Product code LTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)