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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 15, 2026

VITEK 2 AST-N447 TEST KIT Product reference 424620

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

VITEK 2 AST-N447 TEST KIT Product reference 424620

Identifiers to compare

  • UDI 03573026634551
  • Lot 0853293604
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
VITEK 2 AST-N447 TEST KIT Product reference 424620Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.45,900 cardsZ-2715-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

International distribution to the countries of Belgium and the Netherlands.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.