Recall Z-0618-2019— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2018-10-22, terminated 2019-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-22
- Terminated
- 2019-11-04
- Firm location
- Durham, NC, United States
Product description
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.
Reason for recall
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Data sourced from openFDA. This site is unofficial and independent of the FDA.