medical Class III Updated 2020-03-11

Biofire Defense recalls FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)0

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: UT, MD, GA, CO, OH, TX
Lot/Code Info: 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
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