Gene-Up Lysis Kit Recalled Due to Storage Condition Violations
Biomerieux Inc is recalling Gene-Up Lysis Kit (Catalog 414057) because storage conditions were exceeded and product performance cannot be guaranteed. Nationwide distribution.
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 medical device recall involving a diagnostic reagent. No illnesses or injuries have been reported. The product is a risk-of-harm device; storage condition violations mean performance cannot be guaranteed, creating potential for diagnostic failures. Per the rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' warranting a High severity score.
Plain-English summary
Biomerieux Inc has recalled the Gene-Up Lysis Kit, Catalog 414057 (Batch Number 1009334990). The product was distributed nationwide. The recall was initiated because temperature and time storage specifications were exceeded during handling or storage.
When storage or handling conditions are not maintained within specified parameters, the manufacturer cannot guarantee the product will perform as intended. This reagent kit is used in diagnostic and laboratory applications where reliable performance is essential.
Laboratories and healthcare facilities that received affected units should discontinue use immediately and contact Biomerieux Inc for return, replacement, or disposal instructions. Verify your inventory against Batch Number 1009334990 to determine if you have received affected units.
The recalled product
- Product
- GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-condition-failure
- performance-degradation
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 3573026387761
- Batch Numbers: 1009334990
Distribution
Distributed nationwide across the United States.
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