FDA Device recall Z-1077-2018
Epi proColon Plasma Quick Kit
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Epi proColon Plasma Quick Kit by Epigenomics Ag, citing the diagnostic test kit may produce invalid test runs which may delay test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1077-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-02 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Epigenomics Ag |
| Distribution | CA, MI, NC, NE, NJ, NY, PA, TN, TX, UT |
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;
Reason
The diagnostic test kit may produce invalid test runs which may delay test results.
Identifiers
| code_info | Lot Number: 16903908; Expiration Date: 28 Feb 2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1077-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.