Epigenomics Ag: Medical Device Recall in 2018 - (Recall #: Z-1077-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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;

Product Classification:

Class II

Date Initiated: November 2, 2017

Date Posted: March 28, 2018

Recall Number: Z-1077-2018

Event ID: 79364

Reason for Recall:

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

Status: Terminated

Product Quantity: 200

Code Information:

Lot Number: 16903908; Expiration Date: 28 Feb 2018

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated