VITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.
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: This is an FDA Class II recall involving a diagnostic test that could produce false resistant results for high-risk pathogens (carbapenem/cephalosporin resistance), which impacts infection detection and treatment decisions. No reported illnesses or injuries are stated in the source text, but the hazard is clinically significant.
Plain-English summary
Biomerieux Inc is recalling the VITEK 2 AST-N447 TEST KIT (Product reference 424620, Lot 0853293604) distributed to Belgium and the Netherlands. The recall affects 45,900 cards from the affected lot.
The kits have a potential to produce false resistant carbapenem and/or cephalosporin results when analyzing samples with test cards that have pouch foil fractures. This could lead to inaccurate antimicrobial susceptibility testing results.
Users of kits from the affected lot should inspect cards for foil pouch integrity before use. Any cards with foil fractures should not be used for testing.
The recalled product
- Product
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Manufacturer
- Biomerieux Inc
- Affected units
- 45,900
Distribution
Distribution scope not specified by the agency.
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