VIDAS BRAHMS Procalcitonin Test System Recalled for Storage Condition Failure
Biomerieux is recalling 47 units of the VIDAS BRAHMS Procalcitonin test system (Batch 1009301530) after determining that temperature and time exceedances compromised product performance. Affected devices may produce unreliable diagnostic results.
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 an FDA Class II recall involving a risk-of-harm diagnostic device where no illnesses or injuries have been reported. The storage condition exceedances may compromise test accuracy, creating potential for misdiagnosis, but actual harm remains theoretical.
Plain-English summary
Biomerieux Inc is recalling 47 units of the VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T (Catalog 30450-01, Batch 1009301530) due to storage condition failures discovered during quality review.
The recalled devices experienced temperature and time exceedances that exceeded normal operating parameters. As a result, product performance cannot be guaranteed. The devices may produce unreliable diagnostic results.
This recall affects 47 units distributed nationwide in the United States. The affected devices can be identified by Batch Number 1009301530 and UDI/DI 03573026223601.
Biomerieux is notifying customers of the recall. Healthcare facilities and laboratories using the recalled devices should discontinue use and contact Biomerieux for instructions regarding replacement or return.
The recalled product
- Product
- VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-exceedance
- unreliable-results
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 03573026223601
- Batch Numbers: 1009301530
Distribution
Distributed nationwide across the United States.
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