ETEST Minocycline Susceptibility Test Affected by Storage Temperature Exceedance
Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.
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 FDA Class II without reported illnesses or injuries. The hazard is that product performance cannot be guaranteed due to storage exceedance, creating a risk of unreliable diagnostic results. Per the rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Biomerieux Inc is recalling ETEST CLINICAL MINOCYCLINE MC 256 US S30 (Catalog 412407) antibiotic susceptibility test kits nationwide. The affected batch is identified by Batch Number 1009434000 and UDI/DI 03573026378226. A total of 3 units have been distributed across the United States.
The recall was initiated because the affected product units experienced storage conditions (temperature and time) outside the acceptable range. As a result, product performance cannot be guaranteed.
ETEST is a clinical laboratory diagnostic tool used in clinical microbiology settings to determine bacterial antibiotic susceptibility patterns. Laboratories that received this batch should be aware that test results from these affected units may be unreliable.
If you are a clinical laboratory that received this product, stop use of units from this batch and contact Biomerieux for replacement or guidance. Any patient test results generated using affected units from this batch should be reviewed and, if necessary, retested using properly stored materials to ensure accurate antibiotic susceptibility information.
The recalled product
- Product
- ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
- Manufacturer
- Biomerieux Inc
- Hazard
- product-malfunction
- test-unreliability
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 03573026378226
- Batch Numbers: 1009434000
Distribution
Distributed nationwide across the United States.
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