Biofire Defense: Medical Device Recall in 2020 - (Recall #: Z-1448-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 20, 2019

Date Posted: March 11, 2020

Recall Number: Z-1448-2020

Event ID: 84887

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.

Status: Terminated

Product Quantity: 92 kits

Code Information:

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 Pattern:

US: UT, MD, GA, CO, OH, TX, OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated