The Recall Desk
HighFDA (Devices)·Z-2040-2021·Announced 2021-07-14

FilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results

BioFire Diagnostics is recalling 3,559 FilmArray Pneumonia Panel plus test kits globally due to stability failures causing increased false negative results between 6 and 12 months after manufacturing, potentially missing pneumonia diagnoses.

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: This is an FDA Class II recall of a diagnostic device with a documented defect (false negatives) that poses a clear risk of patient harm through missed pneumonia diagnosis. No adverse events are reported in the source material, and the classification is Class II rather than Class I, placing this at the High level per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

BioFire Diagnostics, LLC is recalling the FilmArray Pneumonia Panel plus (Pneumoplus), a molecular diagnostic test used to identify organisms that cause pneumonia. The affected products include the 30-test kit (Part No. RFIT-ASY-0143, UDI 00815381020314) and the 6-test kit (Part No. RFIT-ASY-0142, UDI 00815381020321). The recall was initiated following stability study failures that resulted in an increased rate of false negative results—where the test fails to detect pneumonia when it is present—when tests are performed between 6 and 12 months after manufacturing.

Approximately 3,559 kits have been distributed globally, including across all 50 U.S. states, Washington DC, and U.S. territories, as well as over 60 countries worldwide. The affected test kits are used in hospitals, clinics, and diagnostic laboratories.

Healthcare providers and laboratory directors should discontinue use of the affected test kits and contact BioFire Diagnostics for replacement or refund information.

The recalled product

Product
FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Manufacturer
BioFire Diagnostics, LLC
Category
Medical Device — Diagnostic Test Kit
Hazard
  • false-negative
  • diagnostic-failure

Distribution

Distributed in 47 states:

  • AK
  • AL
  • AZ
  • CA
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NE
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • SC
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI
  • WV
  • WY

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