Recall Z-1140-2024— BioFire Diagnostics, LLC

Name: FDA recall Z-1140-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-26

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2024-01-26. It names 4 FDA 510(k) clearances: K230404, K160459, K143005 and 1 more. Product: 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.. Reason: Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-01-26
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) PanelBiofire Diagnostics, LLC·cleared 2023-03-16
K160459 — FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC·cleared 2016-04-01
K143005 — FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC·cleared 2015-02-19
K140407 — FILMARRAY GASTROINTESTINAL (GI) PANELBiofire Diagnostics·cleared 2014-05-02

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

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.

Reason for recall

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

Data sourced from openFDA. This site is unofficial and independent of the FDA.