ETEST Clinical Colistin Test Product Recalled Due to Storage Conditions
Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were 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 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: This FDA Class II medical device recall involves storage condition failure with no reported illnesses or injuries. The hazard is precautionary—potential diagnostic unreliability due to out-of-range storage, not confirmed harm.
Plain-English summary
Biomerieux Inc is recalling ETEST Clinical Colistin CO 256 US B100 testing products (Batch 1009261260) distributed nationwide in the United States. This product is a clinical diagnostic test used for microbiology testing.
The recall was initiated because storage temperature and time conditions exceeded the safe parameters for this product. When storage conditions fall outside the specified range, the manufacturer cannot guarantee that the product will perform as intended. This could result in unreliable test performance or inaccurate diagnostic results.
Healthcare facilities and laboratories that received affected batches should immediately stop using the product and contact Biomerieux Inc for instructions on replacement or handling. No illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device — Diagnostic Test
- 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 (3)
- UDI/DI 03573026254681
- Batch Numbers: 1009261260
- Research use only
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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