VITEK 2 Reagent Test Kit Recalled Due to Storage Temperature and Time Exceedance
Biomerieux Inc is recalling VITEK 2 Reagent NH Test Kit units nationwide because they were stored outside proper temperature and time parameters. 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 with no reported illnesses, injuries, or confirmed test failures. The recall is precautionary based on storage condition exceedance; product performance cannot be guaranteed, but actual harm has not been reported.
Plain-English summary
Biomerieux Inc is recalling 13 units of the VITEK 2 REAGENT NH TEST KIT VTK2 (Catalog 21346, Batch 2452278203) distributed nationwide to the United States. The recall was initiated because the product was stored outside the specified temperature and time parameters during distribution.
When storage conditions are not maintained within manufacturer specifications, the performance and reliability of diagnostic reagent kits cannot be guaranteed. Product stored outside acceptable ranges may provide inaccurate or unreliable test results.
Laboratories and healthcare facilities that received units from this batch should cease use of the affected product immediately and contact Biomerieux Inc for replacement or proper disposal instructions.
The recalled product
- Product
- VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346
- 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 03573026144357
- Batch Numbers: 2452278203
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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