FDA Recalls VITEK 2 Reagent GP Test Kit Due to Temperature Excursion
Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test 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 recall of diagnostic reagent kit where temperature and time parameters exceeded acceptable ranges, potentially degrading test accuracy. No illnesses or injuries have been reported; the hazard is theoretical performance degradation without reported harm.
Plain-English summary
Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS (Catalog 21342) nationwide. The recall affects 144 units with batch numbers 2422281503 and 2422288503.
The recall was initiated because temperature and time parameters during storage or handling exceeded acceptable ranges. When products experience such excursions, their chemical performance cannot be guaranteed, potentially affecting the accuracy of test results.
Healthcare providers and laboratory professionals using affected units should immediately cease use and contact Biomerieux Inc. for guidance on replacements or procedures to verify test reliability. The affected product UDI/DI is 03573026131920.
The recalled product
- Product
- VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
- Manufacturer
- Biomerieux Inc
- Affected units
- 144
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 (3)
- UDI/DI 03573026131920
- Batch Numbers: 2422281503
- 2422288503
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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