VIDAS Quality Control Product Recalled for Storage Condition Deviation
Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—loss of performance guarantee due to storage condition deviation—rather than direct patient harm. This is consistent with a precautionary recall.
Plain-English summary
Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, Catalog 30706 (Batch 1009351560) nationwide in the United States. The product was distributed in 12-unit packages.
Storage temperature and time conditions for the affected units exceeded specified limits. As a result, the manufacturer cannot guarantee the product will perform to specifications.
This quality control product is used in clinical diagnostic laboratories as part of the VIDAS analyzer system. The nationwide distribution means affected units may be present in clinical labs across the United States.
The recalled product
- Product
- VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
- Manufacturer
- Biomerieux Inc
- Affected units
- 12
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 03573026121631
- Batch Numbers: 1009351560
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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