BioFire Diagnostics, LLC: Medical Device Recall in 2025 - (Recall #: Z-1518-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

Product Classification:

Class II

Date Initiated: February 27, 2025

Date Posted: April 16, 2025

Recall Number: Z-1518-2025

Event ID: 96346

Reason for Recall:

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

Status: Ongoing

Product Quantity: 29 kits

Code Information:

UDI: 00815381020314/Lot# 0979424

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated