Events

Recall of BD FocalPoint"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tripath Imaging, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61444
  • Event Risk Class
    Class 3
  • Event Number
    Z-1643-2012
  • Event Initiated Date
    2011-10-06
  • Event Date Posted
    2012-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108126
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Processor, cervical cytology slide, automated - Product Code MKQ
  • 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.

Device

BD FocalPoint"
  • Model / Serial
    To be obtained
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • 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
  • Product Description
    BD Focal Point"230V LC (Refurbished), Catalog number: 490681. || 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.
  • Manufacturer
    Tripath Imaging, Inc.

Manufacturer

Tripath Imaging, Inc.
  • Manufacturer Address
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA