BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1367-2013 · Initiated March 13, 2013

    Recall

    Recall Number
    Z-1367-2013
    Event Number
    64718
    Firm
    Separation Technology, Inc.
    FEI Number
    1721649
    Product Code
    IFB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 13, 2013
    Posted
    May 23, 2013
    Terminated
    December 24, 2013
    Address
    582 Monroe Rd, Ste 1424, Sanford, FL, 32771-8821

    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.

    Action

    On March 13, 2013, Separation Technology, Inc. sent their customers letters instructing them to complete and return the attached Acknowledgement & Receipt form via fax to (407) 788-3677 and requesting the return of the SlidePrep Plus Cytology Centrifuges to STI for correction. For any questions regarding this recall, call STI Customer Service at (800) 777-6668.

    Distribution

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

    Quantity

    102