The Recall Desk
ModerateFDA (Devices)·Z-0842-2023·Announced 2023-01-11

PPM Clinical CHROMID MRSA diagnostic product recalled due to storage condition exceedance

Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.

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 precautionary recall with no reported performance failures or illnesses. Storage parameters exceeded and product performance cannot be guaranteed, fitting the rubric category of voluntary precautionary recalls.

Plain-English summary

Biomerieux Inc is recalling batch 1009550310 of PPM Clinical CHROMID MRSA S. aureus 20PLT US (catalog 414524), a bacterial identification medium used in clinical laboratories. The product was distributed nationwide.

The recall was initiated because temperature and time storage parameters were exceeded during the product's handling. When storage conditions are not maintained within specification, the product's diagnostic performance cannot be guaranteed.

The recalled product

Product
PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
Manufacturer
Biomerieux Inc
Hazard
  • storage-exceedance

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 03573026420758
  • Batch Numbers: 1009550310

Distribution

Distributed nationwide across the United States.