Recall Z-1242-2019— BioFire Diagnostics, LLC
Class II · Terminated
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2019-03-06, terminated 2022-02-18. It names one FDA 510(k) clearance: K140407. Product: FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.. Reason: Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-06
- Terminated
- 2022-02-18
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-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, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Reason for recall
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
Data sourced from openFDA. This site is unofficial and independent of the FDA.