Events

Safety Alert for BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Becton.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-07-05
  • Event Date Posted
    2012-07-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120705.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bd prepstain™ diti 1.2 and diti 1.2 upgrade kits medical device manufacturer, becton, dickinson and company (bd), has issued a medical device safety alert on bd prepstain™ diti 1.2 (catalogue no.: 750-07024-00, sap: 490670) and diti 1.2 upgrade kits (catalogue no.: 750-07377-02, sap: 491074). bd has confirmed through a complaint investigation that bd prepstain instruments with diti cone may leak. the diti is the tip on the bd prepstain to which a pipette tip attaches that dispenses patient samples into the settling chamber. this issue may affect bd prepstain instruments shipped between 16 february 2011 and november 2011. according to the manufacturer, there are no health or safety risks associated with this issue and there have been no injuries reported. the manufacturer has advised all field service representatives to inspect bd prepstain diti 1.2 installation to ensure the parts are secure. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 5 july 2012.

Device

BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits
  • Manufacturer
    Becton

Manufacturer

Becton