The Recall Desk
HighFDA (Devices)·Z-0838-2023·Announced 2023-01-11

Medical device test kit recalled due to storage temperature and time excursion

Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.

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 FDA Class II medical device is a risk-of-harm product used in clinical laboratories. Storage condition excursions prevent guaranteed performance, creating potential for unreliable results in laboratory testing. No illnesses or injuries have been reported, meeting the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit (Catalog 413438) distributed nationwide. This medical device is used in clinical laboratories.

The recall was issued because the product experienced temperature and time conditions outside specified storage ranges. According to the manufacturer, product performance cannot be guaranteed under these conditions.

The affected batch number is 6712257403, with 34 units included in the recall (UDI/DI 03573026399030). Laboratories and healthcare facilities using this product should be aware of this recall.

The recalled product

Product
VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Test Kit
Hazard
  • performance-degradation
  • storage-condition-excursion

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 03573026399030
  • Batch Numbers: 6712257403

Distribution

Distributed nationwide across the United States.

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