The Recall Desk
ModerateFDA (Devices)·Z-0872-2023·Announced 2023-01-11

Biomerieux Culture Media Recalled Due to Temperature and Time Excursions

Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.

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 due to storage conditions affecting product performance guarantees. No illnesses, injuries, or actual product failures have been reported. The hazard is theoretical loss of performance rather than direct safety risk, making this a precautionary quality-control recall.

Plain-English summary

Biomerieux Inc is recalling the PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT culture media product, identified by batch number 1009389930 and UDI/DI 03573026319953. The product is catalog C6045-TI.

The recall was issued because temperature and time conditions during storage and distribution exceeded the manufacturer's specifications. When products are exposed to such out-of-range conditions, the manufacturer cannot guarantee that the product will perform as intended.

Approximately 20 units of the affected product were distributed nationwide throughout the United States. Users should check for this batch number if they have received culture media from Biomerieux.

If you have received the recalled product, discontinue use immediately and contact Biomerieux Inc for further instructions regarding return or replacement.

The recalled product

Product
PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
Manufacturer
Biomerieux Inc
Hazard
  • temperature-excursion
  • device-performance-loss

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 03573026319953
  • Batch Numbers: 1009389930

Distribution

Distributed nationwide across the United States.