DNA Genotek Inc.: Medical Device Recall in 2020 - (Recall #: Z-3004-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: June 24, 2020

Date Posted: September 30, 2020

Recall Number: Z-3004-2020

Event ID: 86279

Reason for Recall:

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

Status: Terminated

Product Quantity: 74

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.

Voluntary or Mandated:

Voluntary: Firm initiated