The Recall Desk
HighFDA (Devices)·Z-0799-2023·Announced 2023-01-11

VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage

Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.

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 FDA Class II recall involves diagnostic test kits where storage conditions were exceeded, preventing the manufacturer from guaranteeing performance. This represents a risk-of-harm product where diagnostic failure could lead to unreliable Salmonella detection. No illnesses or injuries have been reported.

Plain-English summary

Biomerieux Inc. is recalling VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702, Batch 1009406530) distributed nationwide due to storage conditions that exceeded acceptable temperature and time parameters. Approximately 15 units were affected.

The test kits were stored outside of approved conditions, which means the manufacturer cannot guarantee their performance in detecting Salmonella infections.

No illnesses or injuries have been reported in connection with this recall. However, affected test kits may produce unreliable diagnostic results.

Customers who have received these test kits should contact Biomerieux Inc. for further instructions on this recall.

The recalled product

Product
VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
Manufacturer
Biomerieux Inc
Hazard
  • storage-damage
  • test-malfunction

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 03573026065874
  • Batch Numbers: 1009406530

Distribution

Distributed nationwide across the United States.