Recall Z-1451-2020— BioFire Diagnostics, LLC
Class II · Terminated
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2019-08-08, terminated 2022-04-12. It names 3 FDA 510(k) clearances: K160459, K143005, K140407. Product: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only. Reason: Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-08
- Terminated
- 2022-04-12
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- 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
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Reason for recall
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
Data sourced from openFDA. This site is unofficial and independent of the FDA.