BioFire Diagnostics, LLC recalls FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Recall date
- February 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1518-2025
- FDA classification
- Class II
- Brand / firm
- BioFire Diagnostics, LLC
- Sold / distributed
- OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Why it was recalled
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
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