Recall Z-2514-2024 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BioFire Diagnostics, LLC
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and iden
| Date | Aug 6, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| Reason | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| Root cause | Under Investigation by firm |
| Action | On 07/11/2024, the firm emailed an "URGENT FIELD SAFETY NOTICE" to customers informing them the firm has identified an increased risk of false positive Vibrio/Vibrio Cholerae results when the BIOFIRE GI Panel is used with certain lots of Remel" Cary-Blair transport medium (see Appendix A - Affected Remel" Cary-Blair Lots). Customers are instructed to: -If the BIOFIRE GI Panel is used in conjunction with certain lots of Remel" Cary-Blair (Lot # 743930, 769240, 712258, 782425, 732357, and 742049), positive results for Vibrio/Vibrio Cholerae should be confirmed by another method prior to reporti |
| Quantity | 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test. |
| Distribution | U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, Virgin Island, VT, WA, WI, WV, and WY. O.U.S.: Worldwide - AR, AU, AT, BE, BR, CA, |
| 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 |