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U.S. Department of Health and Human Services

Class 2 Device Recall Epi proColon Plasma Quick Kit

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  Class 2 Device Recall Epi proColon Plasma Quick Kit see related information
Date Initiated by Firm November 02, 2017
Create Date March 16, 2018
Recall Status1 Terminated 3 on June 19, 2018
Recall Number Z-1077-2018
Recall Event ID 79364
PMA Number P130001 
Product Classification System, colorectal neoplasia, DNA methylation and hemoglobin detection - Product Code PHP
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;
Code Information Lot Number: 16903908; Expiration Date: 28 Feb 2018
Recalling Firm/
Manufacturer		 Epigenomics Ag
Geneststr. 5
Berlin Germany
For Additional Information Contact Helen Landicho
914-739-5400
Manufacturer Reason
for Recall		 The diagnostic test kit may produce invalid test runs which may delay test results.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = PHP and Original Applicant = New Day Diagnostics, LLC
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