🔍 RecallPedia

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Class I - Dangerous
🏥 Medical Devices Recalled: February 1, 2023 BioFire Diagnostics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322
  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 temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

Product Codes/Lot Numbers:

Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1253-2023

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