VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion
Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.
What this means for you
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 diagnostic device where storage temperature and time conditions exceeded acceptable limits. The affected test kits present a risk-of-harm through potentially inaccurate diagnostic results, though no illnesses or test failures have been reported.
Plain-English summary
Biomerieux Inc. is recalling the VITEK 2 Reagent AST-GP67 Test Kit (Catalog 22226), a medical device used for antibiotic susceptibility testing in laboratory and clinical settings.
The recall was initiated after it was determined that product in batch 1322258403 experienced storage conditions—specifically temperature and time—that exceeded the acceptable range. When storage parameters are exceeded, product performance cannot be guaranteed.
The affected product was distributed nationwide in the United States. Facilities that may have received this batch should identify affected product and contact Biomerieux Inc. regarding the recall.
The recalled product
- Product
- VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
- Manufacturer
- Biomerieux Inc
- Hazard
- reagent-degradation
- storage-temperature-excursion
- test-performance-failure
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 03573026242060
- Batch Numbers: 1322258403
Distribution
Distributed nationwide across the United States.
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