Class II — DNA Genotek Inc.
| Recalling firm | DNA GENOTEK, INC. |
|---|---|
| Registered facility | DNA GENOTEK, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Evaporation of stabilizing liquid reducing shelf life. |
| Product | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025 |
| Quantity | 2,375,514 (US: 2,148,222 OUS: 227,292) |
| 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 Thail… |
| Initiated | 2022-02-18 |
| Classified | 2022-04-21 |
| Recall number | Z-0981-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DNA Genotek Inc. (Z-0981-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89831/
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