BEUDAMED
    FDA Recall Terminated

    ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA

    Recall: Z-0640-04 · Initiated February 19, 2004

    Recall

    Recall Number
    Z-0640-04
    Event Number
    28384
    Firm
    Vysis
    FEI Number
    1421461
    Product Code
    MMW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 19, 2004
    Posted
    July 20, 2004
    Terminated
    August 27, 2004
    Address
    3100 Woodcreek Dr, Downers Grove, IL, 60515-5427

    Description

    ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA

    Reason

    Some of the control slides did not have adequate cells deposited upon their surface.

    Action

    Vysis telephoned their customers who received the two affected lots of slides beginning on 2/18/04, informing them of the complaints of missing cells on the control slides. The accounts were requested to check their stocks for any remaining slides from these two lots and return them to Vysis for replacement.

    Distribution

    DOmestically to accounts in Michigan, South Carolina, Illinois, Ohio, Connecticut, Arizona, New York, Texas, California, Oklahoma, Maryland, Virginia, Utah, Florida, Louisiana, Montana, Arkansas, Massachusetts, Minnesota, Missouri and North Carolina, and internationally to Germany and Japan.

    Quantity

    234 kits