# FDA recall Z-1077-2018

> **Epigenomics Ag** · Class II · device recall initiated 2017-11-02.

## 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.

## Distribution

Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.

## Key facts

- **Recall number:** Z-1077-2018
- **Recalling firm:** Epigenomics Ag
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-02
- **Report date:** 2018-03-28
- **Termination date:** 2018-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1077-2018

## Citation

> AI Analytics. FDA recall Z-1077-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1077-2018. Source: US FDA. Licensed CC0.

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