🔍 RecallPedia

FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Class I - Dangerous
🏥 Medical Devices Recalled: January 22, 2020 BioFire Diagnostics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.
  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:
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with specific media types. False positive Proteus results from this test may lead to patients receiving improper antibiotic treatment until culture results are available (within 24-48 hours).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Product Codes/Lot Numbers:

All lots of BioFire BCID Panel used with BACT/ALERT¿ blood culture bottles with expiration dates of September 19, 2020 and beyond.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2295-2020

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