Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion
Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.
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: FDA Class II medical device recall. No illnesses or injuries are reported. The hazard is theoretical—product performance degradation is possible but not confirmed to have occurred. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Biomerieux Inc is recalling VITEK MS-DS clinical reagent (Catalog 410893). Thirteen units with batch number 11111288BM and UDI/DI 03573026359096 were distributed nationwide in the United States.
The recall was initiated because the reagent units were exposed to temperature and time conditions that exceeded specified parameters. According to the manufacturer, when these conditions are exceeded, product performance cannot be guaranteed.
The recalled product
- Product
- VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
- Manufacturer
- Biomerieux Inc
- Affected units
- 13
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 03573026359096
- Batch Numbers: 11111288BM
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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