Recall Z-1140-2024 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
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 diagnostic.
| Date | Feb 15, 2024 (initiated Jan 26, 2024) |
| Status | Open, Classified |
| Reason | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| Root cause | Under Investigation by firm |
| Action | On 01/262024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Norovirus results when the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel. Customers are requested to take the following actions: In this context, we request you to take the following actions. Please: - Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. |
| Quantity | 64,594 kits (equals 2,303,760 tests) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140407 | FILMARRAY GASTROINTESTINAL (GI) PANEL Biofire Diagnostics, May 2, 2014 |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC, Feb 19, 2015 |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch Biofire Diagnostics, LLC, Apr 1, 2016 |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Biofire Diagnostics, LLC, Mar 16, 2023 |