Device product
ORAcollect RNA: ORE-100
Z-0982-2022
Product summary
- Firm
- DNA Genotek Inc.
- Event
- Event 89831
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,080 (US: 14, 17,066)
- Official record key
device-enforcement:Z-0982-2022
Official wording
Reason: Evaporation of stabilizing liquid reducing shelf life.
Code information: Lot: YJ530
Distribution pattern: 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.
Derived failure modes
-
Unknown
Evaporation of stabilizing liquid reducing shelf life.