VITEK 2 AST-XN15 Test Kit Recalled for Temperature and Time Storage Failure
Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.
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 Score 3 (High) recall because it represents a risk-of-harm product where test performance cannot be guaranteed, potentially leading to inaccurate diagnostic results. No injury has been reported. Per the severity rubric, risk-of-harm products with unreported injury align with the High category.
Plain-English summary
The VITEK 2 AST-XN15 Test Kit, manufactured by Biomerieux Inc., is being recalled. The product is a laboratory diagnostic reagent kit used in antimicrobial susceptibility testing.
The recall was initiated because the product was exposed to temperature and time conditions that exceeded acceptable ranges. As a result, the manufacturer cannot guarantee that the product will perform as intended. Affected test kits may provide inaccurate results.
The recall affects 58 units that were distributed nationwide in the United States. The affected batch is identified as Batch Number 8312243203, with UDI/DI 03573026620288. This is classified as a Class II recall by the FDA.
The recalled product
- Product
- VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
- Manufacturer
- Biomerieux Inc
- Affected units
- 58
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 03573026620288
- Batch Numbers: 8312243203
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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