Recall Z-1518-2025— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2025-02-27. It names 3 FDA 510(k) clearances: K243222, K222601, K181324. Product: FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374. Reason: Increased risk of control failures and false negative test results with multiplexed nucleic acid test..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-27
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more
- K222601 — FilmArray Pneumonia Panel plus
- K181324 — FilmArray Pneumonia Panel plus
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
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Reason for recall
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Data sourced from openFDA. This site is unofficial and independent of the FDA.