BEUDAMED
    FDA Recall Terminated

    ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001

    Recall: Z-0922-03 · Initiated January 29, 2003

    Recall

    Recall Number
    Z-0922-03
    Event Number
    25529
    Firm
    Cytyc Corporation
    FEI Number
    1000120743
    Product Code
    KEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 29, 2003
    Posted
    June 12, 2003
    Terminated
    October 22, 2003
    Address
    85 Swanson Road, Boxborough, MA, 01719

    Description

    ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001

    Reason

    Microscope Slides contaminated with fungal material

    Action

    On 1/29/03 the firm issued a letter advising users of the problem and requesting they cease using the slides for preparation of non-gynecological cytology specimens. Replacement product has been shipped.

    Distribution

    Nationwide

    Quantity

    5,261 units