Device 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;
Z-1077-2018
Product summary
- Firm
- Epigenomics Ag
- Event
- Event 79364
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200
- Official record key
device-enforcement:Z-1077-2018
Official wording
Reason: The diagnostic test kit may produce invalid test runs which may delay test results.
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.
Derived failure modes
-
Unknown
The diagnostic test kit may produce invalid test runs which may delay test results.