VITEK 2 AST-XN09 test kit recalled for improper storage temperature and time conditions
Biomerieux is recalling VITEK 2 AST-XN09 test kits where performance cannot be guaranteed due to storage outside proper temperature and time parameters. Affected kits nationwide should not be used.
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 medical device with potential for unreliable test performance due to storage condition exceedance. No illnesses or injuries reported; the risk is loss of diagnostic reliability that could impact treatment decisions.
Plain-English summary
Biomerieux Inc is recalling VITEK 2 REAGENT AST-XN09 TEST KIT (catalog 423425) distributed nationwide in the United States. The recalled units include batch number 3122253113 with UDI/DI 03573026618940.
The product was stored outside of acceptable temperature and time parameters. As a result, product performance cannot be guaranteed.
Laboratories and healthcare facilities using these test kits should immediately discontinue use of the affected batch. Contact Biomerieux for instructions regarding return of the product and receipt of replacement units.
The recalled product
- Product
- VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 50
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 03573026618940
- Batch Numbers: 3122253113
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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