Reported Dec 26, 2018 · Terminated
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
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 Systems Software Version 9.01 Update Kit.
- Lot codes and dates
- Product DescriptionKIT UPDT VTK2 9.01 EN
- UDI03573026561260
- Amount recalled
- five (5) VITEK¿ 2 Systems Software version 9.01
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
The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.
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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