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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 94 products in this recall →Related recalls
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