ETEST Ceftriaxone Antibiotic Test Strips Recalled for Storage Condition
Biomerieux is recalling ETEST Clinical Ceftriaxone test strips nationwide because storage temperature and time conditions were exceeded, which may affect product analytical performance.
What this means for you
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 a Class II recall with no reported illnesses, injuries, or analytical failures. The hazard is theoretical—storage excursion may compromise performance but no actual clinical incidents have been reported. The source explicitly states the condition creates uncertainty rather than confirmed damage, making this a precautionary recall.
Plain-English summary
Biomerieux Inc is recalling ETEST Clinical Ceftriaxone TX 32 US S30 antibiotic susceptibility test strips (Catalog 412302, Batch 1009444340) due to storage conditions that exceeded acceptable temperature and time parameters.
These diagnostic test strips are used in clinical laboratories to determine bacterial susceptibility to ceftriaxone antibiotic therapy. When stored outside the specified temperature and time range, the product's analytical performance cannot be guaranteed.
The product was distributed nationwide to clinical laboratories. Biomerieux recommends that healthcare facilities using affected batch numbers verify the integrity and accuracy of any test results generated using this product and consider retesting if applicable.
Users should contact Biomerieux with questions about affected inventory or proper handling and disposal of recalled product.
The recalled product
- Product
- ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
- Manufacturer
- Biomerieux Inc
- Hazard
- analytical-performance
- storage-condition
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 03573026377205
- Batch Numbers: 1009444340
Distribution
Distributed nationwide across the United States.
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