The Recall Desk
HighFDA (Devices)·Z-0848-2023·Announced 2023-01-11

VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

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 diagnostic medical device where storage parameter exceedances may impair test performance. Diagnostic devices used in clinical settings represent a risk-of-harm product category, as incorrect results could lead to inappropriate treatment decisions.

Plain-English summary

Biomerieux Inc. is recalling 39 units of the VITEK 2 Reagent AST-ST02 Test Kit (catalog 420915). The recall is being issued because the temperature and time parameters for storage were exceeded during distribution. As a result, the company cannot guarantee that the product will perform as intended.

The affected batch number is 5412237203, distributed nationwide in the United States. Laboratories and healthcare facilities that have received this product should contact Biomerieux Inc. for further information and instructions regarding the affected batch.

The recalled product

Product
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Test Kit
Hazard
  • performance-degradation
  • 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 (2)

  • UDI/DI 03573026552152
  • Batch Numbers: 5412237203

Distribution

Distributed nationwide across the United States.

Related recalls

Same category