BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116),

Recalled May 8, 2019 · FDA recall Z-1242-2019 · BioFire Diagnostics

Hazard

Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. · FDA Class II

Units

17188

Sold at

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

Description

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

Product

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.

Manufacturer(s)

BioFire Diagnostics, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →