Reported Dec 26, 2018 · Terminated
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog #…
bioMerieux, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402
Is this the product you have?
- VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or
- more of these susceptibility productsCatalog # 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
- Lot codes and dates
Catalog # 410028VITEK 2 AST-ST01 Catalog # 420915VITEK 2 AST-ST02 Catalog # 421040VITEK 2 AST-ST03
- Amount recalled
- 184,374
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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