DNA Genotek Inc. recalls PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Us…

Recall date

June 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3004-2020

FDA classification

Class III

Brand / firm

DNA Genotek Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.

Why it was recalled

Reagents were shipped to customers after the Use by data indicated on its labeling.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.