FDA recall Z-1392-2023

BioFire Diagnostics, LLC · Class II · device

Product

FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

Reason for recall

Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

Distribution

US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.

Key facts

Status
Ongoing
Initiation date
2023-03-08
Report date
2023-04-26
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-1392-2023