FDA Recalls ETEST Clinical Benzylpenicil Test Due to Storage Excursion
Biomerieux Inc recalls ETEST Clinical Benzylpenicil susceptibility test kits due to temperature and time excursions during storage that affect product performance. Batch 1009477980 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 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 is an FDA Class II recall with no reported illnesses or injuries. The hazard is potential performance degradation due to storage excursions; the risk is theoretical with no documented patient harm. Per the rubric, recalls with theoretical hazards and no reported harm are at most 3. The precautionary nature and absence of direct safety impact justify a Moderate (2) rating.
Plain-English summary
Biomerieux Inc is recalling ETEST CLINICAL BENZYLPENICIL PG 256 US S30 susceptibility testing kits (Catalog 412262, Batch 1009477980). These products are used in clinical microbiology laboratories.
The product was exposed to temperature and time excursions during storage that exceeded acceptable ranges. According to the FDA and manufacturer, product performance cannot be guaranteed under these conditions.
The affected batch was distributed nationwide in the United States. Laboratories and healthcare facilities that received this product are advised to contact Biomerieux Inc regarding returns, replacements, or further instructions.
The recalled product
- Product
- ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
- 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 03573026376802
- Batch Numbers: 1009477980
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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