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