Z-3004-2020 Class III Terminated

Recalled by DNA Genotek Inc. — Kanata, N/A

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