ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure
Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.
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: This is an FDA Class II recall of a diagnostic laboratory test. Although no illnesses or injuries have been reported, inaccurate test results from degraded product constitute a risk-of-harm scenario in a clinical setting where incorrect susceptibility testing could affect treatment decisions.
Plain-English summary
Biomerieux Inc is recalling the ETEST Clinical Meropenem MP 32 US S30 (catalog 412401) due to storage condition failures. The recall affects 3 units from batch 03573026378165 that were distributed nationwide in the United States. The company determined that these units experienced temperature and time conditions that exceeded specified storage parameters.
As a result of these storage exceedances, product performances cannot be guaranteed. The affected product is a laboratory susceptibility test used in clinical settings.
Laboratories and healthcare facilities that possess affected units should discontinue use immediately and contact Biomerieux Inc for further instructions regarding product return, replacement, or disposal. Test results from affected units should be considered unreliable.
The recalled product
- Product
- ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
- Manufacturer
- Biomerieux Inc
- Affected units
- 3
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 (3)
- UDI/DI 03573026378165
- Batch Numbers: 03573026378165
- 03573026378165
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.
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