Epigenomics Epi proColon Plasma Quick Kit: Invalid Test Results Risk
Epigenomics recalls Epi proColon Plasma Quick Kit (M5-02-001) due to potential invalid test results. This may delay diagnostic results. No remedy specified in recall notice.
Lower-risk recall
The diagnostic test kit may produce invalid test runs which may delay test results.
Contact the company
What happened, in plain English
Epigenomics is recalling its Epi proColon Plasma Quick Kit (catalog M5-02-001) because it may produce invalid test runs, which could delay diagnostic results. This affects users who rely on this kit for testing. Read more at govinfonow.com/recall/72634-epigenomics-epi-procolon-plasma-quick-kit-invalid-test-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72634-epigenomics-epi-procolon-plasma-quick-kit-invalid-test-results-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1077-2018
Cite this page
“Epigenomics Epi proColon Plasma Quick Kit: Invalid Test Results Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72634-epigenomics-epi-procolon-plasma-quick-kit-invalid-test-results-risk. Based on FDA recall #Z-1077-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1077-2018%22&limit=1).
Why it’s dangerous
The kit may produce invalid test runs, which can delay diagnostic results. This happens because the test kit might not work correctly, leading to inaccurate or no results.
Who’s affected
Users of the Epi proColon Plasma Quick Kit for diagnostic testing are affected. Those who have the kit and use it for medical testing are most at risk of delayed results.
How to tell if you have this one
Check for the catalog number M5-02-001 on the kit. The kit includes 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, and 1x Protection Buffer.
- Brand
Epigenomics- Product
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate- Category
Medical device
What to do — step by step
Check Kit Details
Look for the catalog number M5-02-001 on the kit to confirm it is recalled.
Where it went and when
Where it was distributed
Distributed in 10 states.
FDA distribution: “Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Michigan, Nebraska, New Jersey, New York, North Carolina, Pennsylvania, Tennessee, Texas, Utah.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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-1077-2018 (November 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1077-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 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.