The Recall Desk
HighFDA (Devices)·Z-0856-2023·Announced 2023-01-11

Medical Device Test Kit Recalled Due to Storage Condition Exceedance

Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.

What this means for you

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 with no reported illnesses or injuries. The hazard—degraded product performance due to storage condition exceedance—is theoretical without reported adverse outcomes, placing this at severity level 3 per the rubric criteria for risk-of-harm products without reported injury.

Plain-English summary

Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT (Catalog 423416), a medical device test kit. The recall affects 64 units distributed nationwide in the United States. The affected batch number is 412148504.

The recall was issued because storage temperature and time conditions exceeded acceptable ranges. When these conditions are exceeded, the product's performance cannot be guaranteed, which may affect the reliability of test results.

Healthcare facilities and laboratories that received this test kit should stop using the affected batch and contact Biomerieux Inc. for return or replacement instructions.

The recalled product

Product
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Test Kit
Hazard
  • storage-condition-exceedance
  • performance-degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 03573026618834
  • Batch Numbers: 412148504

Distribution

Distributed nationwide across the United States.

Related recalls

Same category