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;
FDA Recall Z-1077-2018 · Posted None
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Recalling FirmEpigenomics Ag
Recall StatusTerminated
Product CodePHP
Date Initiated2017-11-02
Date Terminated2018-06-19
Product Quantity200
Reason for Recall
The diagnostic test kit may produce invalid test runs which may delay test results.
Firm 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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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