The Recall Desk
HighFDA (Devices)·Z-0822-2023·Announced 2023-01-11

FDA Recalls ETEST Ertapenem Antibiotic Susceptibility Test Due to Storage Damage

Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.

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 recall of a diagnostic device where storage damage may compromise test performance. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation where patient care decisions could be affected by inaccurate results. Per the rubric, risk-of-harm products with no reported injury score as High (3).

Plain-English summary

Biomerieux Inc. is recalling ETEST CLINICAL ERTAPENEM ETP 32 US S30 antibiotic susceptibility test strips due to improper storage conditions. The recalled product (batch 1009491830, UDI/DI 03573026377533) was exposed to temperature and time conditions outside the manufacturer's specifications during distribution.

Antibiotic susceptibility tests are used by clinical microbiology laboratories to determine which antibiotics are effective against bacterial infections. When storage conditions are compromised, the accuracy and reliability of test results cannot be guaranteed.

This recall affects 5 units distributed nationwide in the United States. Clinical laboratories should immediately review whether they have received this batch and take affected units out of service. Test results obtained from these units may be unreliable and should not be used for patient treatment decisions.

Affected facilities should contact Biomerieux Inc. for instructions on product return or replacement.

The recalled product

Product
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Manufacturer
Biomerieux Inc
Category
Medical Device — Clinical Diagnostic Test
Hazard
  • inaccurate-test-results
  • device-malfunction

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 03573026377533
  • Batch Numbers: 1009491830

Distribution

Distributed nationwide across the United States.

Related recalls

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