Recall Z-1077-2018— Epigenomics Ag
Class II · Terminated
Class II FDA medical device recall by Epigenomics Ag, initiated 2017-11-02, terminated 2018-06-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Epigenomics Ag
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-02
- Terminated
- 2018-06-19
- Firm location
- Berlin, N/A, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.