BEUDAMED
    FDA Recall Terminated

    BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

    Recall: Z-1631-2012 · Initiated October 6, 2011

    Recall

    Recall Number
    Z-1631-2012
    Event Number
    61444
    Firm
    Tripath Imaging, Inc.
    FEI Number
    3008007472
    Product Code
    MKQ
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 6, 2011
    Posted
    May 21, 2012
    Terminated
    December 3, 2012
    Address
    780 Plantation Dr, Burlington, NC, 27215-6723

    Description

    BD Focal Point"100V / 15 FOV under 5%, Catalog number: 490364 The BD Focal Point" Slide Profiler (formerly the AutoPap System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

    Reason

    The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached.

    Action

    BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit. For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions. For questions regarding this recall call 918-563-1624.

    Distribution

    Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand

    Quantity

    see line 1.