BioFire Diagnostics, LLC Recall: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 t
BioFire Diagnostics, LLC Recall: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 t is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: BioFire Diagnostics, LLC; Product: FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal mi
| Recalling firm | BioFire Diagnostics, LLC |
|---|---|
| Product | 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 diagnostic. |
| Reason for recall | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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 W |
| Recall initiated | 20240126 |
| Recall number | Z-1140-2024 |
| Category | device |
| State | UT |
| Country | United States |
$29/mo
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