Z-1077-2018Class II

Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B...

Name: Z-1077-2018 Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B...
Creator: Epigenomics Ag
Published: 2017-11-02
License: https://open.fda.gov/license/

Epigenomics AG / initiated 2017-11-02 / Terminated

FDA source

Epigenomics Ag began a recall of 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... on 2017-11-02. FDA classified it as Class II and gives the reason as "The diagnostic test kit may produce invalid test runs which may delay test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1077-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-02
Posted: 2018-03-16
Terminated: 2018-06-19
Recalling firm: Epigenomics AG
Product: 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 code: PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
Reason for recall: The diagnostic test kit may produce invalid test runs which may delay test results.
FDA root cause: Unknown/Undetermined by firm
Action: Users were instructed to discontinue use of the kits, complete the acknowledgement form, and distribute the notification to relevant persons within organization. If kits were further distributed the consignee was asked to forward the safety notice to these entities.
Quantity in commerce: 200
Distribution: Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
Product codes and lots: Lot Number: 16903908; Expiration Date: 28 Feb 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1077-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1077-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-16

Product code PHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)