Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Epi proColon Plasma Quick Kit Recalled by Epigenomics Ag Due to The diagnostic test kit may produce invalid test...

Date: November 2, 2017
Company: Epigenomics Ag
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Epigenomics Ag directly.

Affected Products

Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;

Quantity: 200

Why Was This Recalled?

The diagnostic test kit may produce invalid test runs which may delay test results.

Where Was This Sold?

This product was distributed to 10 states: CA, MI, NE, NJ, NY, NC, PA, TN, TX, UT

Affected (10 states)Not affected

About Epigenomics Ag

Epigenomics Ag has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report