FDA-Device2022-04-27Class II
ORAcollect RNA: ORE-100
DNA Genotek Inc.
Hazard
Evaporation of stabilizing liquid reducing shelf life.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.
Affected count
17,080 (US: 14, 17,066)
Manufactured in
3000-500 Palladium Dr, Kanata, Canada
Products
ORAcollect RNA: ORE-100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2022Don't want to check this manually?
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