bioMerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to False Results
bioMerieux is recalling VITEK 2 Streptococcus Susceptibility Cards because they may produce false resistant results for specific Streptococcus strains.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may provide inaccurate diagnostic results (false resistant results), which poses a risk of harm to patients through potential mismanagement of infections, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
bioMerieux, Inc. is recalling VITEK 2 Antimicrobial Susceptibility Testing (AST) products, specifically the VITEK 2 Streptococcus Susceptibility Cards (Catalog # 410028, 420915, and 421040). The recall is due to reports of false resistant results for Streptococcus anginosus and Streptococcus constellatus strains.
The affected products are intended for use with VITEK 2 Systems in clinical laboratories to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents. A total of 184,374 units were distributed worldwide, including nationwide distribution in the United States and to numerous countries across multiple continents.
Clinical laboratories should stop using the affected VITEK 2 Streptococcus Susceptibility Cards and contact bioMerieux, Inc. for instructions on how to return the products or obtain replacements. The FDA has classified this as a Class II recall.
The recalled product
- 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 u
- Manufacturer
- bioMerieux, Inc.
- Hazard
- Affected units
- 184,374
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog # 410028
- VITEK 2 AST-ST01 Catalog # 420915
- VITEK 2 AST-ST02 Catalog # 421040
- VITEK 2 AST-ST03
Distribution
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