Medical Device Test Kit Recalled Due to Storage Condition Exceedance
Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee 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 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 an FDA Class II recall with no reported illnesses or injuries. The hazard—degraded product performance due to storage condition exceedance—is theoretical without reported adverse outcomes, placing this at severity level 3 per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT (Catalog 423416), a medical device test kit. The recall affects 64 units distributed nationwide in the United States. The affected batch number is 412148504.
The recall was issued because storage temperature and time conditions exceeded acceptable ranges. When these conditions are exceeded, the product's performance cannot be guaranteed, which may affect the reliability of test results.
Healthcare facilities and laboratories that received this test kit should stop using the affected batch and contact Biomerieux Inc. for return or replacement instructions.
The recalled product
- Product
- VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
- Manufacturer
- Biomerieux Inc
- Affected units
- 64
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 03573026618834
- Batch Numbers: 412148504
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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See all →- ModerateVITEK 2 Reagent Test Kit Recalled Due to Storage Temperature and Time Exceedance
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