Recall Z-2671-2025— bioMerieux, Inc.
Class II · Ongoing
Class II FDA medical device recall by bioMerieux, Inc., initiated 2025-06-26. FDA's recall record names no specific 510(k) clearance for this event. 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 only. Reason: Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards.
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-26
- Firm location
- Durham, NC, United States
Product description
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 only
Reason for recall
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Data sourced from openFDA. This site is unofficial and independent of the FDA.