The Recall Desk
HighFDA (Devices)·Z-0787-2023·Announced 2023-01-11

VITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance

Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.

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 a Class II FDA recall where storage condition exceedance may compromise diagnostic test reliability and accuracy, creating risk of diagnostic errors. No illnesses or injuries have been reported, making the hazard theoretical rather than proven.

Plain-English summary

Biomerieux Inc. is recalling 348 units of the VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, catalog 21341, distributed nationwide in the United States. The affected batch numbers are 2412101403, 2412103403, 2412103503, and 2412106403.

The product was recalled because storage conditions exceeded acceptable temperature and time limits. When products are stored outside these parameters, diagnostic performance cannot be guaranteed, potentially resulting in unreliable test results.

This is a Class II recall issued by the FDA. No illnesses or injuries have been reported to date.

The recalled product

Product
VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Test Kit
Hazard
  • inaccurate-results
  • storage-damage

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 (5)

  • UDI/DI 03573026131913
  • Batch Numbers: 2412101403
  • 2412103403
  • 2412103503
  • 2412106403

Distribution

Distributed nationwide across the United States.

Related recalls

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