Reported May 11, 2016 · Terminated
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North…
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 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. 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. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
- Lot codes and dates
- Lot/Serial485368220
- Expiry12-JAN-17
- Amount recalled
- 337 Kits of 20 Cards/Kit
Why it was recalled
Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
This product could cause temporary or reversible health problems — stop using it.
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