Recall archive / FDA device enforcement
ORAcollect RNA: ORE-100 — FDA record Z-0982-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ORAcollect RNA: ORE-100
- Reason
- Evaporation of stabilizing liquid reducing shelf life.
- Classification
- Class II
- Recalling firm
- DNA Genotek Inc.
- Quantity
- 17,080 (US: 14, 17,066)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0982-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: YJ530 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 27, 2022
- Recall initiation date
- Feb 18, 2022
- Center classification date
- Apr 21, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.