The Recall Desk
HighFDA (Devices)·Z-2039-2021·Announced 2021-07-14

FilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives

BioFire Diagnostics is recalling FilmArray Pneumonia Panel test kits globally due to stability failures that increase false negative results between 6 and 12 months of shelf life.

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 a Class II medical device recall for a diagnostic test with demonstrated stability failures causing false negative results. While no illnesses or hospitalizations are reported in the source, false negatives in a pneumonia diagnostic test represent a risk-of-harm to patients, meeting the criteria for a High severity rating.

Plain-English summary

BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel test kits globally due to stability study failures. The affected kits are Part Numbers RFIT-ASY-0144 (30-test kit) and RFIT-ASY-0145 (6-test kit). Approximately 4,462 kits distributed worldwide were subject to this recall.

Real-time stability studies identified an increased rate of false negative test results in kits that were 6 to 12 months old at the time of testing. A false negative occurs when the test fails to detect pneumonia when it is actually present.

The kits were distributed across all US states and territories, as well as more than 80 countries internationally. Healthcare facilities and laboratories using these kits should verify the manufacturing dates of their stock and contact BioFire Diagnostics regarding affected units.

The recalled product

Product
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
Manufacturer
BioFire Diagnostics, LLC
Category
Medical Device — Diagnostic Test Kit
Hazard
  • false-negative-results
  • diagnostic-inaccuracy
  • stability-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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