Recall Z-0703-2024 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BioFire Diagnostics, LLC
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
| Date | Jan 10, 2024 (initiated Nov 27, 2023) |
| Status | Open, Classified |
| Reason | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission. |
| Root cause | Process control |
| Action | On 11/27/23, recall notices were emailed to laboratory directors who were asked to do the following: Discontinue use and discard any remaining pouches that are subject to this recall. 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. Complete and return the acknowledgement form using the following URL: https://www.biofiredx.com/recall5797 Customers with questions can contact Technical Support at biofire |
| Quantity | 53 Kits |
| Distribution | US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD |
| 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 |