Z-1077-2018 Class II Terminated
FDA device recall Z-1077-2018 was initiated by Epigenomics Ag on November 2, 2017 and is designated Class II. Reason for recall: The diagnostic test kit may produce invalid test runs which may delay test results. The recall status is terminated (terminated June 19, 2018). Affected quantity: 200.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 2, 2017
- Termination Date
- June 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200
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;
Reason for Recall
The diagnostic test kit may produce invalid test runs which may delay test results.
Distribution Pattern
Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
Code Information
Lot Number: 16903908; Expiration Date: 28 Feb 2018