ETEST Clinical Amoxicillin/Clavulanic Acid Test System Recalled Due to Storage Excursion
Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.
What this means for you
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 a Class II medical device recall where storage excursions have compromised product integrity and performance cannot be guaranteed. Although no illnesses or injuries have been reported, this represents a risk-of-harm situation where diagnostic test accuracy could be affected, potentially leading to incorrect clinical decisions.
Plain-English summary
Biomerieux Inc is recalling the ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30 test system (catalog 412252, batch 1009311920) from nationwide distribution.
The recall was initiated because temperature and time storage parameters were exceeded during product handling or storage. As a result, the product's performance cannot be guaranteed. These test systems are used for antibiotic susceptibility testing in clinical and diagnostic laboratory settings.
The recalled product was distributed nationwide. Affected laboratories and healthcare facilities should discontinue use of the affected batch and contact Biomerieux Inc for replacement or proper disposition.
No illnesses or injuries related to this recall have been reported to the FDA.
The recalled product
- Product
- ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-excursion
- test-performance-risk
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 03573026376703
- Batch Numbers: 1009311920
Distribution
Distributed nationwide across the United States.
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