Device product
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, 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.
Z-1403-2015
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 70645
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1505 cartons
- Official record key
device-enforcement:Z-1403-2015
Official wording
Reason: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Code information: lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
Distribution pattern: Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
Derived failure modes
-
Unknown
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.