The Recall Desk
ModerateFDA (Devices)·Z-0839-2023·Announced 2023-01-11

Biomerieux CHROMID CARBA Laboratory Product Recalled Due to Storage Condition Violations

Biomerieux Inc is recalling CHROMID CARBA laboratory products nationwide because storage conditions exceeded acceptable temperature and time ranges. The company cannot guarantee 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 with no reported illnesses or documented product failures. The hazard is potential performance degradation due to storage condition violations, which is precautionary in nature. Per the rubric, voluntary precautionary recalls with no reported harm are typically scored as Moderate.

Plain-English summary

Biomerieux Inc is recalling PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT (catalog 414012), a laboratory product distributed nationwide.

The recall was initiated because storage conditions exceeded acceptable temperature and time parameters. When exposed to such conditions, the manufacturer cannot guarantee that the product will perform as intended.

Batch 2147080 is affected. Laboratory and healthcare facility personnel who have received this product should contact their supplier or Biomerieux Inc for replacement or return instructions. No illnesses or documented product failures have been reported in connection with this recall.

The recalled product

Product
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
Manufacturer
Biomerieux Inc
Hazard
  • improper-storage
  • diagnostic-failure

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 03573026409913
  • Batch Numbers: 2147080

Distribution

Distributed nationwide across the United States.