VITEK 2 AST-N447 TEST KIT Product reference 424620
USVITEK 2 AST-N447 TEST KIT Product reference 424620
Recalling Firm: Biomerieux Inc
Reason for Recall / Hazard
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Product Description & Identification
VITEK 2 AST-N447 TEST KIT Product reference 424620
Affected Products
VITEK 2 AST-N447 TEST KIT Product reference 424620
Additional Source Details
| Field | Value |
|---|---|
| City | Hazelwood |
| State | MO |
| Event id | 99213 |
| Address 1 | 595 Anglum Rd |
| Address 2 | N/A |
| Code info | Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only. |
| Postal code | 63042-2320 |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 45,900 cards |
| Reason for recall | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Letter |
| Center classification date | 20260709 |
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Overview
- Recalling FirmBiomerieux Inc
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the countries of Belgium and the Netherlands.
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🚨 SAFETY ALERT: Biomerieux Inc - VITEK 2 AST-N447 TEST KIT Product reference 424620 Check if your household is affected: https://therecallfile.com/recalls/vitek-2-ast-n447-test-kit-product-reference-424620/FDA-Z-2715-2026
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