Antimicrobial susceptibility test cards recalled over false colistin resistance results
bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: erroneous susceptibility results can misdirect antibiotic therapy, and no patient harm is reported.
Plain-English summary
VITEK 2 Gram-negative AST test kits (cards) containing colistin formulation cs02n are being recalled. VITEK 2 is an automated system of instruments, software and reagent cards used for the identification and antimicrobial susceptibility testing of bacteria.
The affected cards carry a potential for false resistant results for colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex. A false resistant result could lead a laboratory to report that an isolate is not susceptible to colistin when it is.
The recall covers 235,269 cards, including material number 423936 (AST-N412 test kit, 20 cards). Distribution listed in the enforcement record is international. The FDA has classified the action as Class II.
Laboratories should identify affected batch numbers and follow bioMerieux's instructions on confirmatory testing and reporting of colistin results for these organisms.
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…
- Manufacturer
- bioMerieux, Inc.
- Category
- Medical Device — Diagnostic test
- Affected units
- 235,269
Distribution
Distribution scope not specified by the agency.
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