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Devices
Device Recall Epi proColon Plasma Quick Kit
Model / Serial
Lot Number: 16903908; Expiration Date: 28 Feb 2018
Product Classification
Hematology and Pathology Devices
Device Class
3
Implanted device?
No
Distribution
Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
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;
Manufacturer
Epigenomics Ag
1 Event
Recall of Device Recall Epi proColon Plasma Quick Kit
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Manufacturer
Epigenomics Ag
Manufacturer Address
Epigenomics Ag, Geneststr. 5, Berlin Germany
Manufacturer Parent Company (2017)
Epigenomics AG
Source
USFDA
Language
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