Home / Recalls / BioFire Diagnostics, LLC / Z-1518-2025

Z-1518-2025 Class II Ongoing

Recalled by BioFire Diagnostics, LLC — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
April 16, 2025
Initiation Date
February 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29 kits

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.

Distribution Pattern

OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel

Code Information

UDI: 00815381020314/Lot# 0979424

Other recalls by BioFire Diagnostics, LLC

  • Z-0602-2026 Class II — BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) (October 22, 2025)
  • Z-1877-2025 Class II — BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems (April 30, 2025)
  • Z-3122-2024 Class II — FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W (August 7, 2024)
  • Z-3123-2024 Class II — FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U (August 7, 2024)
  • Z-2456-2024 Class II — BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FI (June 19, 2024)
  • Z-2682-2024 Class II — BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 (June 10, 2024)
  • Z-2683-2024 Class II — BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 (June 10, 2024)
  • Z-2514-2024 Class II — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) (May 16, 2024)
  • Z-1139-2024 Class II — BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACT (January 26, 2024)
  • Z-1140-2024 Class II — FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-010 (January 26, 2024)