FDA Recalls ETEST Fluconazole Susceptibility Test due to Storage Excursion
Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 susceptibility testing kits due to storage temperature and time excursions that prevent performance verification. Affected batch 1009172020 is distributed nationwide.
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: Class II medical device recall where storage conditions exceeded specifications and product performance cannot be guaranteed. Classified as a risk-of-harm situation for a diagnostic product with no reported illness or injury, per rubric criterion for products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 US S30 (Catalog 412333) antimicrobial susceptibility testing kits distributed nationwide. The product is used in clinical microbiology laboratories. The affected batch number is 1009172020.
Storage conditions for the product were exceeded (temperature and/or time out of range). As a result, the manufacturer cannot guarantee product performance. For a diagnostic test, unverified performance could affect the reliability of susceptibility test results.
Healthcare facilities that received affected batch 1009172020 should stop using the product and contact Biomerieux Inc. for disposition instructions and replacement product, if needed.
The recalled product
- Product
- ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
- Manufacturer
- Biomerieux Inc
- Affected units
- 2
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 03573026377717
- Batch Numbers: 1009172020
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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