Reported Apr 1, 2020 · Terminated
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and…
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 card AST-N371 - Product UsageThe VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
- Lot codes and dates
- REF422024
- Lot Number0210932204
- Amount recalled
- 4,130 kits (82,600 cards)
Why it was recalled
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
This product could cause temporary or reversible health problems — stop using it.
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