Z-0982-2022 Class II Ongoing
FDA device recall Z-0982-2022 was initiated by DNA Genotek Inc. on February 18, 2022 and is designated Class II. Reason for recall: Evaporation of stabilizing liquid reducing shelf life. The recall status is ongoing. Affected quantity: 17,080 (US: 14, 17,066).
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- February 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,080 (US: 14, 17,066)
Product Description
ORAcollect RNA: ORE-100
Reason for Recall
Evaporation of stabilizing liquid reducing shelf life.
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.
Code Information
Lot: YJ530