FDA Medical Device Recalls (openFDA)
DNA Genotek Inc.: 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 number
- Z-3004-2020
- Recalling firm
- DNA Genotek Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-06-24
- Posted
- not on file
- Terminated
- 2021-11-01
- Reason
- Reagents were shipped to customers after the Use by data indicated on its labeling.
- Root 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
- 74
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
- Lot, serial or model codes
- Lot PT-Q2A WE11
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 3003742580
- Firm city
- Kanata
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28