FDA recall Z-1448-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-08-20

Report date

2020-03-11

Termination date

2020-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2020