Z-0982-2022 Class II Ongoing
FDA device recall Z-0982-2022 was initiated by DNA Genotek Inc. on Feb 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
- Apr 27, 2022
- Initiation Date
- Feb 18, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0982-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026