Recall Z-2514-2024— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2024-05-16. It names 4 FDA 510(k) clearances: K230404, K160459, K143005 and 1 more. Product: 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 identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.. Reason: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-16
- 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 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 identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
Reason for recall
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
Data sourced from openFDA. This site is unofficial and independent of the FDA.