🔍 RecallPedia

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

Class I - Dangerous
🏥 Medical Devices Recalled: January 26, 2021 BioFire Diagnostics Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
  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:
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

Product Codes/Lot Numbers:

All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1157-2021

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