VITEK 2 Test Cards Recalled for Inaccurate Susceptibility Testing Results
bioMerieux is recalling 235,269 VITEK 2 Gram-negative test cards that may produce false resistant results when testing multidrug-resistant Pseudomonas and Acinetobacter bacteria for Colistin. Distributed internationally, the cards may provide inaccurate antibiotic susceptibility information.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with potential for false susceptibility test results affecting high-risk multidrug-resistant pathogens. The hazard is serious in principle but theoretical, with no clinical harm documented in the source, justifying a High rating rather than Severe.
Plain-English summary
VITEK 2 Gram-negative AST test cards are diagnostic kits used in clinical laboratories to identify bacteria and measure their resistance to antibiotics. The VITEK 2 automated system is widely used to guide antibiotic treatment decisions.
bioMerieux, Inc. is recalling 235,269 VITEK 2 test cards containing Colistin formulation (cs02n) due to the potential for false resistant results. The issue specifically affects test cards when used to evaluate multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex—organisms commonly resistant to many antibiotics. A false resistant result would incorrectly indicate that Colistin is ineffective against the bacteria when it may actually be effective.
The recalled cards were distributed internationally to clinical laboratories in Albania, Armenia, Australia, Austria, Belgium, and numerous other countries. Specific lot numbers affected by this issue are detailed in the FDA recall notice.
Healthcare facilities should identify affected lots and discontinue their use immediately. Contact bioMerieux or the FDA for guidance on replacement or return procedures.
The recalled product
- Product
- VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. 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. Export o
- Manufacturer
- bioMerieux, Inc.
- Hazard
- inaccurate-testing
Distribution
Distribution scope not specified by the agency.
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