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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 Kitsee related information
Date Initiated by FirmNovember 02, 2017
Create DateMarch 16, 2018
Recall Status1 Terminated 3 on June 19, 2018
Recall NumberZ-1077-2018
Recall Event ID 79364
PMA NumberP130001 
Product Classification System, colorectal neoplasia, DNA methylation and hemoglobin detection - Product Code PHP
ProductEpi 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
FEI Number 3005968611
Recalling Firm/
Manufacturer		 Epigenomics Ag
Geneststr. 5
Berlin Germany
For Additional Information ContactHelen 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
ActionUsers 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 Commerce200
DistributionShipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = PHP
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