VITEK 2 AST-GN95 Diagnostic Test Kit Recalled for Performance Failure
Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.
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 of a medical device whose performance cannot be guaranteed due to storage condition failures. Although no injuries or illnesses have been reported, the hazard of inaccurate antimicrobial susceptibility test results—which could lead to inappropriate patient treatment—qualifies this as a risk-of-harm product, meeting the rubric criterion for Score 3.
Plain-English summary
Biomerieux Inc. is recalling the VITEK 2 AST-GN95 test kit (catalog 421982) used for antimicrobial susceptibility testing in laboratory and clinical settings. The recall involves 84 units with batch number 6852245503.
The recall was initiated because storage and handling conditions exceeded acceptable temperature and time parameters, preventing performance guarantees.
The affected units were distributed nationwide in the United States. Facilities or individuals with units from batch 6852245503 should consult Biomerieux Inc. for guidance on appropriate actions.
The recalled product
- Product
- VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
- Manufacturer
- Biomerieux Inc
- Affected units
- 84
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 03573026565923
- Batch Numbers: 6852245503
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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