Class 3 Device Recall PrepIT.Q2A

• Date Initiated by Firm: June 24, 2020
• Create Date: September 23, 2020
• Recall Status: Terminated 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/ Manufacturer: 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: 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.