FDA Device recall Z-3004-2020
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 re…
- FDA Device
- Class III
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class III recall of 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 re… by Dna Genotek, citing reagents were shipped to customers after the Use by data indicated on its labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3004-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-24 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Dna Genotek |
| Distribution | US |
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
Reagents were shipped to customers after the Use by data indicated on its labeling.
Identifiers
| code_info | Lot PT-Q2A WE11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3004-2020%22
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