VITEK 2 BCL Test Kit recalled for storage condition violations
A batch of VITEK 2 Reagent BCL Test Kit from Biomerieux Inc is being recalled because storage conditions were exceeded, and product performance cannot be guaranteed.
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 based on storage condition violation that cannot guarantee product performance. No illnesses, injuries, or actual harm reported. This meets the criteria for Moderate severity as a precautionary quality-control-based recall without documented harm.
Plain-English summary
The VITEK 2 Reagent BCL Test Kit (Catalog 21345) manufactured by Biomerieux Inc is being recalled due to storage condition violations affecting batch 2392195203.
The product was stored outside of the acceptable temperature and time ranges. As a result, the product's performance cannot be guaranteed.
The affected batch was distributed nationwide in the United States.
The recalled product
- Product
- VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
- Manufacturer
- Biomerieux Inc
- Affected units
- 1
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 353026131951
- Batch Numbers: 2392195203
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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