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.
This recall has been terminated (originally issued June 24, 2020).
- Recall Initiated
- June 24, 2020
- Terminated
- November 1, 2021
- Recall Number
- Z-3004-2020
- Quantity
- 74
- Official Source
- View on FDA website ↗
Reason for Recall
Reagents were shipped to customers after the Use by data indicated on its labeling.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
Lot / Code Info
Lot PT-Q2A WE11
Root Cause
Process control
Action Taken
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.