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Biomerieux Inc recalls bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine
Recalled April 3, 2013 · FDA recall Z-1013-2013 · Biomerieux
Hazard
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. · FDA Class II
Units
4/20-card cartons
Sold at
Distributed only in HI.
Description
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Product
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.
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →