FDA recall Z-0982-2022

DNA Genotek Inc. · Class II · device

Product

ORAcollect RNA: ORE-100

Reason for recall

Evaporation of stabilizing liquid reducing shelf life.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-02-18
Report date
2022-04-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kanata, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2022