The Recall Desk
HighFDA (Devices)·Z-0857-2023·Announced 2023-01-11

VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions

Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.

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: FDA Class II medical device with potential for unreliable test performance due to storage condition exceedance. No illnesses or injuries reported; the risk is loss of diagnostic reliability that could impact treatment decisions.

Plain-English summary

Biomerieux Inc is recalling VITEK 2 REAGENT AST-XN09 TEST KIT (catalog 423425) distributed nationwide in the United States. The recalled units include batch number 3122253113 with UDI/DI 03573026618940.

The product was stored outside of acceptable temperature and time parameters. As a result, product performance cannot be guaranteed.

Laboratories and healthcare facilities using these test kits should immediately discontinue use of the affected batch. Contact Biomerieux for instructions regarding return of the product and receipt of replacement units.

The recalled product

Product
VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics / Laboratory Test
Hazard
  • inaccurate-diagnostics

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 03573026618940
  • Batch Numbers: 3122253113

Distribution

Distributed nationwide across the United States.

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