The Recall Desk
HighFDA (Devices)·Z-1518-2025·Announced 2025-04-16

FilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures

BioFire Diagnostics is recalling 29 units of the FilmArra Pneumonia Panel Plus test kit due to control failures and false negative results. Affected units (Lot 0979424) were distributed to France, Italy, Spain, Switzerland, and Israel.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries in the source. The hazard involves false negative test results in a pneumonia diagnostic kit and control failures that could prevent test validation, representing a risk-of-harm scenario where injury has not yet been reported.

Plain-English summary

BioFire Diagnostics, LLC is recalling 29 units of the FilmArra Pneumonia Panel Plus (Pneumoplus) diagnostic test kit, Reference RFIT-LBL-0374, Lot 0979424. This multiplexed nucleic acid test is designed to diagnose pneumonia infections.

The recall addresses an increased risk of control failures and false negative test results. Control failures prevent proper validation of test results, while false negatives allow infected patients to remain undiagnosed.

The affected units were distributed internationally to France, Italy, Spain, Switzerland, and Israel.

The recalled product

Product
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Manufacturer
BioFire Diagnostics, LLC
Category
Medical Device — Laboratory Diagnostics
Hazard
  • false-negative-results
  • control-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 00815381020314/Lot# 0979424

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category