🔍 RecallPedia

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

Class I - Dangerous
🏥 Medical Devices Recalled: August 20, 2019 Biofire Defense Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10
  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 Defense
Reason for Recall:
The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

Product Codes/Lot Numbers:

Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10

Distribution:

Distributed in: US, UT, MD, GA, CO, OH, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1448-2020

Related Recalls

JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.

Biofire Defense

Class I - Dangerous

BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.

Aug 13, 2014 Diagnostic Equipment Nationwide View Details →