Z-3004-2020Class III

PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL -

Name: Z-3004-2020 PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL -
Creator: DNA Genotek Inc.
Published: 2020-06-24
License: https://open.fda.gov/license/

DNA Genotek Inc. / initiated 2020-06-24 / Terminated / root cause: manufacturing process

FDA source

DNA Genotek Inc. began a recall of 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... on 2020-06-24. FDA classified it as Class III and gives the reason as "Reagents were shipped to customers after the Use by data indicated on its labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3004-2020
Classification: Class III
Status: Terminated
Initiated: 2020-06-24
Posted: 2020-09-23
Terminated: 2021-11-01
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.
Product code: PPM General Purpose Reagent
Reason for recall: Reagents were shipped to customers after the Use by data indicated on its labeling.
Root cause tag: manufacturing process
FDA 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 [email protected].
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.
Product codes and lots: Lot PT-Q2A WE11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3004-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3004-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-23

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)