medical Class II Updated 2018-12-26

bioMerieux, Inc. recalls VITEK 2 Antimicrobial Susceptibility Testing (AST) using one

Recalled Product

VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.


Hazard / Issue

False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03
View official government recall

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