Events

Safety Alert for BD PrepStain Slide Processors

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

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
    2013-08-16
  • Event Date Posted
    2013-08-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816a.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 slide processors medical device manufacturer, bd has issued a medical device safety alert concerning the following prepstain slide processors: prepstain ag with catalogue numbers 05cr00021, 05cr00021r, 05cr00022, 05cr00022r, 05cr00023 and 05cr00023r prepstain tecan us-i with catalogue numbers 799-13000-00 and 799-13000-00r prepstain tecan us-ii with catalogue numbers 799-14000-00 (490100) and 799-14000-00r (490407) based on a report from the field, bd has determined that a prepstain slide processor rack setting was incorrectly entered on one prepstain system during a routine preventive maintenance visit by a bd field service representative. this incorrect rack setting has the potential to cause a sample mismatch for specimen test results. to determine whether a device is impacted by a similar error, bd advises users to observe a full 48 slide run (approximately 45 minutes) that will verify the appropriate gyn and non-gyn prepstain system operations during sample transfer. the rack setting inspection procedure is described in the safety notice. if the instrument is not impacted by this issue, no further action will be necessary. if the instrument is impacted, a bd service representative will schedule an on-site visit to adjust the rack settings. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BD PrepStain Slide Processors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD PrepStain Slide Processors
  • Manufacturer
    BD

Manufacturer

BD