PrepIT Q2A Kit — Class III medical device recall Z-3004-2020
Terminated recall by DNA Genotek Inc., reported 2020-09-30, distributed nationwide. Reagents were shipped to customers after the Use by data indicated on its labeling.
| Recall number | Z-3004-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DNA Genotek Inc., Kanata, N/A, Canada |
| Recall initiated | 2020-06-24 |
| Classified | 2020-09-23 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2021-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN |
| Quantity | 74 |
| Reason classes | labeling |
| Lot numbers | PT-Q2A, WE11 |
| Model numbers | PT-Q2A-96 |
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.
Reason for recall
Reagents were shipped to customers after the Use by data indicated on its labeling.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3004-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.