BEUDAMED
    FDA Enforcement Class II Terminated

    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.

    Recall: Z-1367-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1367-2013
    Event ID
    64718
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Separation Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    March 13, 2013
    Classification Date
    May 23, 2013
    Termination Date
    December 24, 2013
    Address
    582 Monroe Rd Ste 1424, N/A, Sanford, FL, 32771-8821, United States

    Description

    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.

    Reason

    Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.

    Code Info

    Serial numbers: 0110, 0111, 0112, 0210, 0211, 0212, 0310, 0311, 0312, 0410, 0411, 0412, 0511, 0512, 0611, 0710, 0711, 0811, 0812, 0910, 0911, 0912, 1011, 1012, 1112, 1210, 1212.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.

    Quantity

    102