Events

Safety Alert for TheraSphere Yttrium 90 Glass Microspheres

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

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
    2015-09-23
  • Event Date Posted
    2015-09-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923b.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: biocompatibles uk therasphere yttrium 90 glass microspheres medical device manufacturer, biocompatibles uk (btg), has issued a medical device safety alert concerning its therasphere yttrium 90 (y-90) glass microspheres. the affected products are identified as follows:- lot number: 1599211; manufacturing date: 03-sep-2015; calibration date: 06-sep-2015; expiry date: 18-sep-2015 the manufacturer has recently become aware, via a customer complaint, of the mislabeling of one dose vial of therasphere y-90 glass microspheres lot 1599211 that was distributed in hong kong. the therasphere vial was labeled 10 gbq and the actual dose was 5 gbq (total radioactivity was incorrect). mislabelling of the therasphere y-90 glass microspheres may result in under- or over-dosing of the patient resulting in the patient not receiving their prescribed dose. under-dosing could result in lack of efficacy, and over-dosing could result in non-target tissue radiation. the manufacturer advises users to verify the accuracy of the dose measurement prior to administration. this recommendation is consistent with the therasphere training and reference material that the manufacturer provides to each user. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

TheraSphere Yttrium 90 Glass Microspheres
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biocompatibles UK TheraSphere Yttrium 90 Glass Microspheres
  • Manufacturer
    Biocompatibles UK

Manufacturer

Biocompatibles UK
  • Manufacturer Parent Company (2017)
    Btg Plc
  • Source
    DH