Epigenomics Ag recalls Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1…

Recall date

November 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1077-2018

FDA classification

Class II

Brand / firm

Epigenomics Ag

Sold / distributed

Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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;