Recall Z-0703-2024— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-11-27. It names 4 FDA 510(k) clearances: K230404, K160459, K143005 and 1 more. Product: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.. 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..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-27
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
4 on FDA's record- K230404 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K160459 — FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
- K143005 — FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
- K140407 — FILMARRAY GASTROINTESTINAL (GI) PANEL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.