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

Recall date

August 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1448-2020

FDA classification

Class III

Brand / firm

Biofire Defense

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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