The Recall Desk
ModerateFDA (Devices)·Z-0844-2023·Announced 2023-01-11

Laboratory Culture Medium Recalled Due to Storage Condition Failure

Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.

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: This is an FDA Class II recall for a laboratory culture medium where storage conditions were exceeded. No illnesses or injuries have been reported, and the hazard is impaired product performance rather than direct injury risk.

Plain-English summary

Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar 100 PLT (Catalog 418049, UDI/DI 03573026466435) due to storage conditions that exceeded acceptable temperature and time parameters.

When temperature and time storage conditions are exceeded, the product's performance cannot be guaranteed. Affected laboratory units may not perform reliably for their intended diagnostic or analytical use.

The recalled product was distributed nationwide in the United States. The affected batch number is 1009462900. If you have received this product, do not use it. Contact Biomerieux Inc for return instructions or replacement.

The recalled product

Product
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
Manufacturer
Biomerieux Inc
Hazard
  • impaired-performance
  • storage-damage

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 03573026466435
  • Batch Numbers: 1009462900

Distribution

Distributed nationwide across the United States.