Device 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.
Z-3004-2020
Product summary
- Firm
- DNA Genotek Inc.
- Event
- Event 86279
- Status
- Terminated
- Classification
- Class III
- Quantity
- 74
- Official record key
device-enforcement:Z-3004-2020
Official wording
Reason: Reagents were shipped to customers after the Use by data indicated on its labeling.
Code information: Lot PT-Q2A WE11
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
Derived failure modes
-
Unknown
Reagents were shipped to customers after the Use by data indicated on its labeling.