FDA Medical devices recall ·
VITEK 2 AST-N447 TEST KIT Product reference 424620 recall
- Recall number
- Z-2715-2026
- Date
- (initiated June 4, 2026)
- Company / brand
- Biomerieux Inc
595 Anglum Rd, Hazelwood, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45,900 cards
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Why was it recalled?
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Distribution
International distribution to the countries of Belgium and the Netherlands.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2715-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.