ETEST Vancomycin Susceptibility Test Recalled Due to Storage Damage
Biomerieux recalled ETEST vancomycin susceptibility tests after storage temperature and time excursions that may compromise product reliability and test accuracy.
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 risk-of-harm product (clinical diagnostic device) where product accuracy cannot be guaranteed due to storage temperature and time excursions. No illnesses or injuries have been reported. The potential for harm exists through incorrect test results, but the hazard remains theoretical without documented adverse events.
Plain-English summary
Biomerieux Inc. is recalling ETEST Clinical ETEST Vancomycin VA M100 susceptibility testing devices (Catalog 423788) because the product was stored at temperatures and for durations outside the manufacturer's specifications. As a result, the manufacturer cannot guarantee the product will perform as intended.
These tests are used by clinical laboratories to assess antibiotic resistance in patient samples and inform treatment decisions. If test results are inaccurate due to storage damage, laboratory professionals may make incorrect clinical decisions about patient treatment.
The recalled product was distributed nationwide in batch 1009351550. Healthcare providers and laboratories that have received this batch should contact Biomerieux Inc. for guidance on handling and replacement of the affected units.
The recalled product
- Product
- ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-temperature-excursion
- diagnostic-accuracy-compromise
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 03573026618780
- Batch Numbers: 1009351550
Distribution
Distributed nationwide across the United States.
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