The Recall Desk
ModerateFDA (Devices)·Z-0855-2023·Announced 2023-01-11

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.

What this means for you

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
Category
Medical Device — Diagnostic Reagent
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 03573026608514
  • Batch Numbers: 1009407250

Distribution

Distributed nationwide across the United States.

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