Reported Jul 14, 2021 · Terminated
FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)…
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 plus (Pneumoplus) Part NumbersPart
- NoRFIT-ASY-0143 /
- UDI00815381020314 (30
- test kit) Part NoRFIT-ASY-0142 /
- UDI00815381020321 (6 test kit)
- Lot codes and dates
- Part NoRFIT-ASY-0144 /
- UDI00815381020178 (30
- test kit) Part NoRFIT-ASY-0145 /
- UDI00815381020185 (6 test kit)
- Amount recalled
- 3,559 kits (Globally)
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
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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