Medical Device Reagent Recalled for Temperature Storage Condition Failure
Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is product performance degradation due to storage condition exceedance, representing a theoretical rather than confirmed failure scenario.
Plain-English summary
Biomerieux Inc is recalling GENE-UP REAGENT GENE-UP Salmonella 2 (Catalog 423105, Batch 1009407250) following determination that storage temperature and time limits were exceeded during product handling. As a result, the manufacturer cannot guarantee the product's performance specifications.
This medical device reagent was distributed nationwide across the United States.
Healthcare facilities and laboratories that received affected batches should immediately discontinue use of this product. Contact Biomerieux Inc with questions about replacement or proper disposal procedures.
The recalled product
- Product
- GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
- 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 03573026608514
- Batch Numbers: 1009407250
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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