ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage
Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.
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 FDA Class II medical device recall for a clinical laboratory test kit. No illnesses or injuries have been reported. The hazard is theoretical—storage excursion may compromise test accuracy. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 US S30 clinical microbiology test kits. These kits are used in laboratory settings to test bacterial antibiotic resistance.
The recall was initiated because the affected kits experienced temperature and time storage conditions outside acceptable specifications. Due to this storage excursion, the performance and accuracy of these test kits cannot be guaranteed.
The affected batch (1009432150) was distributed nationwide. Facilities using these kits should discontinue use and contact Biomerieux Inc for replacements. Unreliable test results from compromised kits could affect clinical treatment decisions.
The recalled product
- Product
- ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
- Manufacturer
- Biomerieux Inc
- Affected units
- 7
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 03573026378950
- Batch Numbers: 1009432150
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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