FDA Recall
Terminated
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;
Recall: Z-1077-2018
·
Initiated November 2, 2017
Recall
- Recall Number
- Z-1077-2018
- Event Number
- 79364
- Firm
- Epigenomics Ag Geneststr. 5 Berlin Germany
- FEI Number
- 3005968611
- Product Code
- PHP
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- November 2, 2017
- Terminated
- June 19, 2018
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
The diagnostic test kit may produce invalid test runs which may delay test results.
Action
Users were instructed to discontinue use of the kits, complete the acknowledgement form, and distribute the notification to relevant persons within organization. If kits were further distributed the consignee was asked to forward the safety notice to these entities.
Distribution
Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
Quantity
200