Device product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 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.
Z-1639-2016
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 73413
- Status
- Terminated
- Classification
- Class I
- Quantity
- 495 kits
- Official record key
device-enforcement:Z-1639-2016
Official wording
Reason: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Code information: Lots 736336020 exp. 2/25/16, 736340920 exp. 4/14/16, and 736388620 exp. 8/4/17.
Distribution pattern: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Derived failure modes
-
Unknown
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.