Home / Recalls / DNA Genotek Inc. / Z-3004-2020

Z-3004-2020 Class III Terminated

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

FDA device recall Z-3004-2020 was initiated by DNA Genotek Inc. on Jun 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 Nov 1, 2021). Affected quantity: 74.

Recall details

Product Type: Devices
Report Date: Sep 30, 2020
Initiation Date: Jun 24, 2020
Termination Date: Nov 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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3004-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.