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U.S. Department of Health and Human Services

Class 3 Device Recall PrepIT.Q2A

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  Class 3 Device Recall PrepIT.Q2A see related information
Date Initiated by Firm June 24, 2020
Create Date September 23, 2020
Recall Status1 Terminated 3 on November 01, 2021
Recall Number Z-3004-2020
Recall Event ID 86279
Product Classification General purpose reagent - Product Code PPM
Product 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.
Code Information Lot PT-Q2A WE11
Recalling Firm/
DNA Genotek Inc.
3000-500 Palladium Dr
Kanata Canada
For Additional Information Contact Austin Udocor
613-723-5757 Ext. 2245
Manufacturer Reason
for Recall
Reagents were shipped to customers after the Use by data indicated on its labeling.
FDA Determined
Cause 2
Process control
Action Customer notification letters were sent to customers on 6/24/20. Actions to be taken by customer: DNA Genotek Inc. recommends the following actions depending on the scenario that applies to you: " You have processed samples using PT-Q2A-96 after 1st May 2020 (Lot WE11 only): o If you have used PT-Q2A Lot WE11 in sample processing, contact your DNA Genotek Inc. Account Manager to schedule a discussion with our R&D and Technical support teams if required. o Your Account Manager will work with you on a replacement shipment. " You have unused PT-Q2A-96 (Lot WE11 only): o Please discard immeditately. Reply to this letter confirming all affected product have been discarded. The quantity discarded will be required in your reply. o Please contact your Account Manager to request a replacement shipment. " You have ordered PT-Q2A Reagents but have not received them: o Your order should not be impacted. o If you do receive Lot WE11, please discard immediately and reply to this letter confirming all affected products have been discarded. o Contact your Account Manager to request a replacement shipment. If you have any additional questions or concerns pertaining to this letter, please contact your DNA Genotek Account Manager or email regulatory@dnagenotek.com.
Quantity in Commerce 74
Distribution Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.