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.
FDA Recall Z-3004-2020 · Posted None
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Recalling FirmDNA Genotek Inc.
Recall StatusTerminated
Product CodePPM
Date Initiated2020-06-24
Date Terminated2021-11-01
Product Quantity74
Reason for Recall
Reagents were shipped to customers after the Use by data indicated on its labeling.
Firm 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 [email protected].
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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