🔍 RecallPedia

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Class I - Dangerous
🏥 Medical Devices Recalled: April 16, 2021 BioFire Diagnostics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BioFire Diagnostics, LLC
Reason for Recall:
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Product Codes/Lot Numbers:

Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1944-2021

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