FilmArray Pneumonia Panel diagnostic test kits recalled for false results
BioFire Diagnostics is recalling 9 FilmArray Pneumonia Panel test kits due to manufacturing defects causing false positive and negative test results, as well as control failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device recall involving diagnostic inaccuracy. No illnesses or injuries have been reported in the source, and the hazard remains theoretical without documented patient harm. Per the rubric, Class II recalls without hospitalization reports are scored as High (3).
Plain-English summary
BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel test kits (model REF RFIT-ASY-0144). The affected kits have UDI 00815381020178, kit lot number 0938121, and pouch lot number 19T621. Approximately 9 kits were distributed in the United States.
The kits are being recalled due to elevated rates of false positive and false negative test results, as well as control failures. These defects were traced to issues in the manufacturing process.
The kits were distributed to facilities in Minnesota and Oklahoma. Any healthcare facility or laboratory using these kits should discontinue use and contact BioFire Diagnostics for further guidance.
The recalled product
- Product
- FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 9
Distribution
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