Epi proColon Plasma Quick Kit — Class II medical device recall Z-1077-2018
Terminated recall by Epigenomics Ag, reported 2018-03-28, distributed in CA, MI, NC, NE, NJ, NY, PA, TN…. The diagnostic test kit may produce invalid test runs which may delay test results.
| Recall number | Z-1077-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epigenomics Ag, Berlin, N/A, Germany |
| Recall initiated | 2017-11-02 |
| Classified | 2018-03-16 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2018-06-19 |
| Distributed | CA, MI, NC, NE, NJ, NY, PA, TN, TX, UT |
| Quantity | 200 |
| UPC / GTIN / UDI-DI | 04260400670036 |
| Lot numbers | 16903908 |
| Model numbers | M5-02-001 |
| Expiration dates | 2018-02-28 |
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 for recall
The diagnostic test kit may produce invalid test runs which may delay test results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1077-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.