BEUDAMED
    FDA Enforcement Class III Terminated

    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).

    Recall: Z-2316-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2316-2017
    Event ID
    77062
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtest Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    October 23, 2014
    Classification Date
    June 8, 2017
    Termination Date
    November 17, 2017
    Address
    5449 Research Dr, N/A, Canton, MI, 48188-2261, United States

    Description

    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).

    Reason

    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.

    Code Info

    HEC200: " 616UE, Mfr. Date 2013-02, Exp. 2017-01 " 652UE, Mfr. Date 2013-07, Exp. 2017-07 " 720UE, Mfr. Date 2014-08, Exp. 2018-07 HNC200: " 858UN, Mfr. Date 2013-07, Exp. 2018-07 " 941 UN, Mfr. Date 2014-07, Exp. 2018-06

    Distribution

    US Nationwide Distribution

    Quantity

    10260 volume vials