FDA Recalls VITEK 2 AST-GN79 Reagent Test Kit for Temperature Excursion
Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT (batches 5992201403 and 5992253503) nationwide because temperature and time conditions exceeded specified ranges, preventing guaranteed product 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 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 deaths. The hazard is degraded product performance from storage-condition excursions, not an immediate safety threat.
Plain-English summary
Biomerieux Inc. is recalling 310 units of the VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, Catalog 413436, with batch numbers 5992201403 and 5992253503. These units were distributed nationwide.
Temperature and time conditions exceeded specified ranges for the product. When storage conditions are not maintained within specification, product performance cannot be guaranteed.
Any entity in possession of product from the recalled batches should discontinue use and contact Biomerieux Inc. for replacement or disposal instructions.
The recalled product
- Product
- VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
- Manufacturer
- Biomerieux Inc
- Affected units
- 310
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 03573026399016
- Batch Numbers: 5992201403
- 5992253503
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.
See all 94 products in this recall →Related recalls
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