🔍 RecallPedia

FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Class I - Dangerous
🏥 Medical Devices Recalled: March 6, 2019 BioFire Diagnostics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots with an expiration date of 23 October 2019 onward
  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 results for Campylobacter and Cryptosporidium have been identified.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Product Codes/Lot Numbers:

Lots with an expiration date of 23 October 2019 onward

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1242-2019

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