Recall Z-1392-2023— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-03-08. It names 2 FDA 510(k) clearances: K143005, K140407. Product: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit). Reason: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-08
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
2 on FDA's record- 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 Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Reason for recall
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.