VITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance
Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. 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 where storage condition exceedance may compromise diagnostic test reliability and accuracy, creating risk of diagnostic errors. No illnesses or injuries have been reported, making the hazard theoretical rather than proven.
Plain-English summary
Biomerieux Inc. is recalling 348 units of the VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, catalog 21341, distributed nationwide in the United States. The affected batch numbers are 2412101403, 2412103403, 2412103503, and 2412106403.
The product was recalled because storage conditions exceeded acceptable temperature and time limits. When products are stored outside these parameters, diagnostic performance cannot be guaranteed, potentially resulting in unreliable test results.
This is a Class II recall issued by the FDA. No illnesses or injuries have been reported to date.
The recalled product
- Product
- VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
- Manufacturer
- Biomerieux Inc
- Affected units
- 348
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 (5)
- UDI/DI 03573026131913
- Batch Numbers: 2412101403
- 2412103403
- 2412103503
- 2412106403
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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