🔍 RecallPedia

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Class I - Dangerous
🏥 Medical Devices Recalled: March 8, 2023 BioFire Diagnostics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109
  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:
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Product Codes/Lot Numbers:

Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1392-2023

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