Levofloxacin ETEST Clinical Test Recalled for Improper Storage Conditions
Biomerieux Inc. is recalling 7 units of ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Batch 1009240000) due to temperature and time storage condition violations that prevent guarantee of 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 involving storage condition violations. No reported illnesses or injuries. The recall is precautionary, affecting a limited quantity (7 units) of a single batch, with straightforward remediation through product discontinuation and replacement.
Plain-English summary
Biomerieux Inc. is recalling ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 diagnostic test kits (Catalog 412392) in Batch 1009240000. The product is an antimicrobial susceptibility test used in clinical laboratories to determine bacterial resistance to levofloxacin.
The recall was issued because temperature and time storage conditions were exceeded during product handling or distribution. When storage conditions are not maintained within specification, the diagnostic performance of the test cannot be guaranteed, potentially resulting in inaccurate test results.
This product was distributed nationwide in the United States. Seven units are affected. Laboratories and healthcare facilities that have received this product should discontinue use and contact Biomerieux Inc. for a replacement or further instructions.
The recalled product
- Product
- ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 7
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 03573026378073
- Batch Numbers: 1009240000
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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