The Recall Desk
HighFDA (Devices)·Z-0859-2023·Announced 2023-01-11

ETEST Meropenem antibiotic susceptibility test recalled due to storage excursion

Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was 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: FDA Class II classification with potential diagnostic performance degradation due to storage excursions. No reported illnesses or injuries. The hazard—unreliable test results—represents a risk-of-harm to patients through potential misdiagnosis, but without confirmed clinical consequences.

Plain-English summary

Biomerieux Inc is recalling ETEST CLINICAL ETEST MEROPENEM MP M100 US diagnostic tests (Catalog 423786) distributed nationwide. The recall affects batch number 1009462290.

The product was found to have experienced storage conditions exceeding recommended temperature and time parameters. Due to these storage excursions, the manufacturer cannot guarantee the device's performance and accuracy in antibiotic susceptibility testing.

Affected healthcare facilities and laboratories should discontinue use of the recalled product. Contact Biomerieux Inc or check the FDA website for instructions on obtaining replacement units or alternative products.

The recalled product

Product
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic / Laboratory Testing
Hazard
  • test-reliability
  • diagnostic-failure

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 03573026618766
  • Batch Numbers: 1009462290

Distribution

Distributed nationwide across the United States.

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