BEUDAMED
    FDA Recall 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 · Initiated October 23, 2014

    Recall

    Recall Number
    Z-2316-2017
    Event Number
    77062
    Firm
    Medtest Holdings, Inc.
    FEI Number
    1827821
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 23, 2014
    Terminated
    November 17, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    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.

    Action

    An technical bulletin/advisory was issued to alert users of the MedTest DX Chemistry Controls catalog numbers HNC200 and HEC200 that revisions have been made for the assigned ranges when used with Arkray Spotchem - EZ Dry Chemistry Analyzer. Customer label corrections were sent to customers who purchased the affected control lots on the following dates: " 10/23/14 technical bulletin HEC200101014 via US mail. " 12/3/14 technical bulletin HNCHEC200120114 via US mail. " 4/6/15 technical bulletin HNCHEC200031015 via US mail. " 5/29/15 technical bulletin HNC200052115 via US mail and email.

    Distribution

    US Nationwide Distribution

    Quantity

    10260 volume vials