Berlin, N/A, Germany
Epigenomics Ag recalls
1 recall recorded since 2018, most recently on 2 November 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 November 2017
- Terminated
- 19 June 2018
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1077-2018
- 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)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.