BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
  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:
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Product Codes/Lot Numbers:

UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2683-2024

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