Reported Sep 27, 2017 · Terminated
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of…
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 · 595 Anglum Rd · Hazelwood, MO · 63042-2320
Is this the product you have?
- VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 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
Lot Number 2420240403Exp. 24-JUL-182420303403Exp 24-SEP-2018
- Amount recalled
- 11,703 cartons
Why it was recalled
Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC¿ 700327(TM) strain is positive.
This product could cause temporary or reversible health problems — stop using it.
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