The Recall Desk
HighFDA (Devices)·Z-0789-2023·Announced 2023-01-11

Medical Device Test Kit Recalled Due to Storage Temperature and Time Excursions

Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's 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 a medical device (risk-of-harm product) where storage condition excursions may compromise performance and test accuracy. No illnesses or injuries have been reported, which per the severity rubric caps the score at High (3).

Plain-English summary

Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT (Catalog 21343, Batch Number 2432261103) distributed nationwide in the US. The recall was initiated because the product experienced temperature and time exposures that exceeded acceptable ranges during storage. The manufacturer states that when such conditions are exceeded, product performance cannot be guaranteed.

This is a Class II recall issued by the FDA.

The recalled product

Product
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Test Kit
Hazard
  • storage-condition-excursion
  • test-accuracy-compromise

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 03573026131937
  • Batch Numbers: 2432261103

Distribution

Distributed nationwide across the United States.

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