Clinical reagent recalled due to temperature and time excursion
Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Class II FDA recall due to temperature and time excursions affecting clinical reagent performance—a risk-of-harm product. No illnesses or injuries have been reported, meeting the criterion for severity score 3 per the rubric.
Plain-English summary
Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA (Catalog 411071). The recall affects 46 units with batch numbers 1009391190, 1009434380, and 1009472100, distributed nationwide in the United States.
The recall was initiated because temperature and time conditions exceeded acceptable ranges. As a result, product performance cannot be guaranteed. Healthcare facilities and laboratories that have received affected batches should contact the manufacturer. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
- Manufacturer
- Biomerieux Inc
- Affected units
- 46
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 (4)
- UDI/DI 03573026362836
- Batch Numbers: 1009391190
- 1009434380
- 1009472100
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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