Reported Apr 26, 2023 · Ongoing
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/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 Gastrointestinal (GI) Panel for FILMARRAY Systems
- REF
RFIT-ASY-0116(30 pouches/kit)
- Lot codes and dates
- Pouch Lot# 2N3R22 / Kit Lot# 2160422
- UDI-DI(00)815381020109
- Amount recalled
- 900 pouches (30 kits)
Where it was sold
Why it was recalled
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
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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