Reported May 8, 2019 · Terminated
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116),…
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, IVD, Rx Only, Biofire Diagnostics
- LLC REF
RFIT-ASY-0104and RFIT-ASY-0116)
- Product UsageThe FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems
- Lot codes and dates
- Lots with an expiration date of 23 October 2019 onward
- Amount recalled
- 17188
Where it was sold
Why it was recalled
Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.
This product could cause temporary or reversible health problems — stop using it.
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