Events

Recall of Device Recall PrepStain AG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

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
    65779
  • Event Risk Class
    Class 2
  • Event Number
    Z-2110-2013
  • Event Initiated Date
    2013-07-08
  • Event Date Posted
    2013-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120125
  • 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
    Prepstain system rack setting was incorrectly entered on one prepstain system during a routine preventive maintenance visit by a bd field service representative.
  • Action
    Ex-US BD sites were notified via email and teleconference, and will communicate directly with customer sites in their region as required by local regulation. All US customers were initially contacted via telephone and letters were mailed.

Device

Device Recall PrepStain AG
  • Model / Serial
    Catalog Numbers - 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, 05CR00023R
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and Puerto Rico and the country of Canada.
  • Product Description
    PrepStain AG. || For use in the screening and detection of cervical cancer.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA