FDAFDA · Food and drugs·Recall number Z-1641-2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Published May 18, 2016 · Recall initiated: February 24, 2016
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
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
- Lot
- Lots 740340920 exp. 4/14/16, 740350820 exp. 7/22/16, 740356320 exp. 9/15/16, 740361110 exp. 11/2/16, 740371720 exp. 2/16/17, 740386420 exp. 7/13/17, and 740388520 exp. 8/3/17.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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