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Recall Observatory FDA recall evidence

Device 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;

Z-1077-2018

November 02, 2017

Class II

Product summary

Firm
Epigenomics Ag
Event
Event 79364
Status
Terminated
Classification
Class II
Quantity
200
Official record key
device-enforcement:Z-1077-2018

Official wording

Reason: The diagnostic test kit may produce invalid test runs which may delay test results.

Code information: Lot Number: 16903908; Expiration Date: 28 Feb 2018

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The diagnostic test kit may produce invalid test runs which may delay test results.