Device recall
Z-3004-2020: PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96)…
FDA device recall · Class III · DNA Genotek Inc.
Key facts
| Recall number (Z-number) | Z-3004-2020 |
|---|---|
| Recall event | 86279 |
| 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. |
| Product code | PPM |
| Recalling firm | DNA Genotek Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 1, 2021 |
| FEI number | 3003742580 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database