ETEST Clinical Imipenem Susceptibility Test Kits Recalled Due to Storage Deviation
Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 susceptibility test kits nationwide because temperature and time storage conditions were exceeded, which may affect 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, based on a manufacturing/storage deviation that may impact product performance. This fits the rubric criterion for 'voluntary precautionary recalls' classified as Moderate.
Plain-English summary
Biomerieux Inc. is recalling ETEST Clinical Imipenem IP 32 US S30 susceptibility test kits (Catalog 412373, Batch Number 1009371780) because the product was exposed to temperature and time conditions outside specified ranges during storage. This deviation may affect the performance and reliability of the test results.
The affected batch was distributed nationwide in the United States. This product is used in clinical laboratories for antimicrobial susceptibility testing to guide treatment decisions.
Healthcare facilities and laboratories that have received this batch should discontinue use and contact Biomerieux Inc. for replacement product. Test results obtained from the affected batch should be reviewed in consultation with Biomerieux Inc., and repeat testing may be considered if clinically indicated.
The recalled product
- Product
- ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
- Manufacturer
- Biomerieux Inc
- Affected units
- 2
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 03573026377953
- Batch Numbers: 1009371780
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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