Z-3004-2020 Class III Terminated
FDA device recall Z-3004-2020 was initiated by DNA Genotek Inc. on June 24, 2020 and is designated Class III. Reason for recall: Reagents were shipped to customers after the Use by data indicated on its labeling. The recall status is terminated (terminated November 1, 2021). Affected quantity: 74.
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- June 24, 2020
- Termination Date
- November 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
Code Information
Lot PT-Q2A WE11