PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: September 30, 2020 Initiated: June 24, 2020 #Z-3004-2020

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.

Details

Recalling Firm
DNA Genotek Inc.
Units Affected
74
Distribution
Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
Location
Kanata, N/A

Frequently Asked Questions

What product 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.. Recalled by DNA Genotek Inc.. Units affected: 74.
Why was this product recalled?
Reagents were shipped to customers after the Use by data indicated on its labeling.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 30, 2020. Severity: Low. Recall number: Z-3004-2020.