Reported Apr 16, 2025 · Ongoing
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- FilmArra Pneumonia Panel plus (Pneumoplus)
- REFRFIT-LBL-0374
- Lot codes and dates
- UDI00815381020314/Lot# 0979424
- Amount recalled
- 29 kits
Why it was recalled
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
This product could cause temporary or reversible health problems — stop using it.
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