BioFire Diagnostics, LLC: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagn

Hazard

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Details from the source

Reason for recall: Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, US Virgin Island, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Albania, Armenia, Argentina, Austria, Australia, Quantity: 64,594 kits (equals 2,303,760 tests) Lot/code info: Part No.: RFIT-ASY-0116 (30 test kit) UDI-DI code: 00815381020109 Part No. RFIT-ASY-0104 (6 test kit) UDI-DI code: 0081538102011

UPC codes

00815381020109, 0081538102011

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.