Class III — DNA Genotek Inc.
| Recalling firm | DNA GENOTEK, INC. |
|---|---|
| Registered facility | DNA GENOTEK, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Reagents were shipped to customers after the Use by data indicated on its labeling. |
| Product | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits. |
| Quantity | 74 |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China. |
| Initiated | 2020-06-24 |
| Classified | 2020-09-23 |
| Terminated | 2021-11-01 |
| Recall number | Z-3004-2020 |
| 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 III recall — DNA Genotek Inc. (Z-3004-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86279/
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