FDAFDA · Food and drugs·Recall number Z-1402-2015
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Published April 15, 2015 · Recall initiated: February 25, 2015
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 outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
- Lot
- lot 740340920, expiration 14APR16; lot 740350820, expiration 22JUL16;
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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