Reported Jun 30, 2021 · Terminated
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
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?
- FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
- Lot codes and dates
- Part NumberRFIT-ASY-0144
- UDI00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621
- Amount recalled
- 9 kits (U.S. only)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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