Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FilmArray Pneumonia Panel (Pneumo) Recalled by BioFire Diagnostics, LLC Due to Due to manufacturing issue, panels may result in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioFire Diagnostics, LLC directly.
Affected Products
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Quantity: 24 Kits (30 pouches/kit)
Why Was This Recalled?
Due to manufacturing issue, panels may result in false negative results.
Where Was This Sold?
This product was distributed to 24 states: CA, CO, CT, FL, GA, IL, IN, IA, LA, MA, MI, MO, MT, NE, NJ, NM, NY, NC, OH, OK, PA, TN, UT, WV
About BioFire Diagnostics, LLC
BioFire Diagnostics, LLC has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report