FDAFDA · Food and drugs·Recall number Z-1013-2013
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.
Published April 3, 2013 · Recall initiated: February 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- Distributed only in HI.
- Lot
- lot number: 540274420
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.