Lower riskMedical device recall · FDA · Published June 24, 2020
DNA Genotek PrepIT Q2A Kit Recall: Reagents Expired Before Use
DNA Genotek recalls PrepIT Q2A Kit (Model PT-Q2A-96) due to reagents shipped after their use-by date. This may cause inaccurate results if used after expiration.
“DNA Genotek PrepIT Q2A Kit Recall: Reagents Expired Before Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64913-dna-genotek-prepit-q2a-kit-recall-reagents-expired-before-use. Based on FDA recall #Z-3004-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3004-2020%22&limit=1).
The FDA announced on June 24, 2020, that DNA Genotek Inc. is recalling the PrepIT Q2A Kit (Model PT-Q2A-96) because reagents were shipped after their use-by date. The recall affects 74 units distributed worldwide.
How to tell if you have it
Brand: DNA Genotek
Product: PrepIT Q2A Kit, Model PT-Q2A-96
Lot code: PT-Q2A WE11
The hazard
The reagents in the recalled kits were shipped to customers after the use-by data indicated on the labeling. The product is used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
Context
GovInfoNow's records show DNA Genotek Inc. has one other recall on record since Feb. 18, 2022: the ORAcollect RNA ORE-100 for evaporation reducing shelf life. Other recent recalls of similar products include Healthmark ProChek-II (July 29, 2026), Biomerieux VITEK 2 AST-N461 Test Kit (July 24, 2026), and Healthmark ProChek Protein Tests (July 29, 2026).
How to tell if you have this one
Check for the model number PT-Q2A-96 on the kit. The affected lot is PT-Q2A WE11. This kit is used for removing SDS and other inhibitors from oral DNA samples.
Brand
DNA Genotek
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Expiration
Verify the use-by date on the kit's label to ensure it hasn't expired.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Maryland, Massachusetts, Minnesota, New York, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3004-2020 (June 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3004-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.