BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

    Recall: Z-2121-2017 · Initiated May 15, 2014

    Recall

    Recall Number
    Z-2121-2017
    Event Number
    77083
    Firm
    Medtest Holdings, Inc.
    FEI Number
    1827821
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 15, 2014
    Posted
    May 20, 2017
    Terminated
    June 2, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

    Reason

    The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

    Action

    Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship. All product shipped after 05/15/2014 included the updated package inserts. Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific.

    Distribution

    Nationwide

    Quantity

    132919 Vol vials