FDA-Device2019-05-08Class II

FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

BioFire Diagnostics, LLC
Hazard

Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.

Sold states
Worldwide Distribution - US Nationwide in the states of: CO, IL, NJ, PA, OH, FL, KY, NE, NY, CA, WV, UT, TX, MS, OK, WI, NC, DE, IN, MN, AK, ND, GA, AR, MO, KS, HI, IA, LA, VA, SC, MT, NM, SD, AL, WY, AZ, WA, TN, OR, MI, MA, NV, MD, CT, DC, VT, ID, NH, RI, ME. Foreign (OUS): Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Ivory Coast, Chile, Colombia, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Hong Kong, Hungary, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, South Africa, Utd.Arab Emir., Puerto Rico,Dutch Antilles,Angola, Bangladesh, Burkina Faso, Bulgaria, Bahrain, Bermuda, Botswana, Dem. Rep. Congo, Costa Rica, Dominican Rep., Algeria, Ecuador, Estonia, Egypt, Gabon, Georgia, Guatemala, Guam, Croatia, Haiti, Israel, Iraq, Jordan, Kenya, Kuwait, Lebanon, Morocco, Macedonia, Malta, Malaysia, Nicaragua, Oman, Panama, Peru, Philippines, Pakistan, Qatar, Romania, Serbia, Saudi Arabia, Slovenia, El Salvador, Uruguay, Vietnam, Denmark, Slovakia
Affected count
17188
Manufactured in
515 S Colorow Dr, N/A, Salt Lake City, UT, United States
Products
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1242-2019

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