Home / Recalls / Biofire Defense / Z-1448-2020

Z-1448-2020 Class III Terminated

Recalled by Biofire Defense — Salt Lake City, UT

Recall Details

Product Type: Devices
Report Date: March 11, 2020
Initiation Date: August 20, 2019
Termination Date: October 30, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 92 kits

Product Description

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

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.

Distribution Pattern

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

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