DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada
Lot Codes / Batch Numbers
Lot PT-Q2A WE11
Products Sold
Lot PT-Q2A WE11
DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada is recalling PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) due to Reagents were shipped to customers after the Use by data indicated on its labeling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reagents were shipped to customers after the Use by data indicated on its labeling.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026