Biomerieux VITEK 2 AST-GN99 Diagnostic Test Kit Recalled for Storage Stability
Biomerieux Inc is recalling 187 units of VITEK 2 REAGENT AST-GN99 TEST KIT due to storage temperature and time exceedances that may compromise 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 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: This FDA Class II recall involves a stability/condition issue with no reported illnesses or injuries. The hazard is theoretical—potential test unreliability due to storage exceedance—rather than a known pathogen or direct harm scenario. Per the rubric, recalls with no reported illness and theoretical hazards fall under voluntary precautionary recalls (score 2).
Plain-English summary
Biomerieux Inc is recalling 187 units of the VITEK 2 REAGENT AST-GN99 TEST KIT, Catalog 423102, Batch Number 6892251103, which was distributed nationwide in the United States.
The recall was issued because the product experienced temperature and time conditions that exceeded specified storage parameters during shipment or storage. When these conditions are exceeded, the performance and reliability of the diagnostic test kit cannot be guaranteed.
The VITEK 2 AST-GN99 TEST KIT is used in clinical and hospital laboratories for antibiotic susceptibility testing of gram-negative bacteria. Laboratories that received affected units should immediately discontinue use of the product.
If you received product with batch number 6892251103, contact Biomerieux Inc for replacement product or further instructions. Do not use the affected units for patient testing.
The recalled product
- Product
- VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
- Manufacturer
- Biomerieux Inc
- Affected units
- 187
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 03573026608132
- Batch Numbers: 6892251103
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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