Reported Mar 18, 2020 · Terminated
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
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 Gastronintestinal (GI) Panel
- REF
RFIT-ASY-01046-pack kitUDI (01)00815381020116CE IVDRx Only
- Lot codes and dates
- Kit Lot0537319 /
- Pouch Lot681619 Pouch Lot Date of Expiration 2020-05-30
- Amount recalled
- 23 kits (690 pouches)
Where it was sold
Why it was recalled
Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.
This product could cause temporary or reversible health problems — stop using it.
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