Recall Z-0149-2027— BioFire Diagnostics, LLC

Name: FDA recall Z-0149-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2026-08-12. It names one FDA 510(k) clearance: K243222. Product: Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A. Reason: Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results.

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-08-12
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K243222 — BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 moreBiofire Diagnostics, LLC (Biomerieux)·cleared 2024-11-06

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

Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A

Reason for recall

Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

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