CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report
Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux
Biomerieux is recalling Vitek 2 Ast-N447 Test Kit Product reference 424620. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2715-2026
- FDA event ID
- 99213
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2026
- FDA classified
- 9 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 4 Jun 2026 | Recall initiated by company | |
| 9 Jul 2026 | Classified by FDA | +35 days |
| 15 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
VITEK 2 AST-N447 TEST KIT Product reference 424620
Where it was distributed
International distribution to the countries of Belgium and the Netherlands.
Questions about this recall
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.
Which lots are affected?
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Where was it sold?
International distribution to the countries of Belgium and the Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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