The Recall Desk
HighFDA (Devices)·Z-0817-2023·Announced 2023-01-11

ETEST Amikacin Test Strips Recalled for Storage Condition Excursion

Biomerieux is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 test strips (batch 1009209480) because temperature and time storage conditions were exceeded, and product performance cannot be guaranteed.

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 recall where storage conditions exceeded specifications, compromising product performance. This is a risk-of-harm product where test reliability cannot be assured, though no illnesses or injuries have been reported.

Plain-English summary

Biomerieux Inc is recalling ETEST CLINICAL AMIKACIN AK 256 US S30 antibiotic susceptibility test strips (catalog 412218, batch number 1009209480) distributed nationwide in the United States.

The product was recalled because temperature and time storage conditions were exceeded during distribution. As a result, product performance cannot be guaranteed.

Customers who have received affected product from batch 1009209480 should contact Biomerieux Inc for guidance on proper handling and replacement options.

The recalled product

Product
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Test
Hazard
  • storage-excursion
  • test-reliability

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 03573026376567
  • Batch Numbers: 1009209480

Distribution

Distributed nationwide across the United States.

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