Events

Safety Alert for Captia™ Varicella-Zoster Virus IgG Kit

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

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
    2012-06-11
  • Event Date Posted
    2012-06-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120611.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: trinity biotech captia™ varicella-zoster virus igg kit medical device manufacturer, trinity biotech, has issued a field safety notice concerning captia™ varicella-zoster virus igg kit. the affected kit lot numbers are 2325600-566, 2325600-567, 2325601-566 and 2325601-567. the manufacturer noted that a drop in absorbance value of the calibrator may occur. this could result in an invalid test run, with the calibrator running low causing the positive control to run high out of its assigned isr range. if the test resulted in a valid run, such as all kit controls and calibrator met quality control criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results was not necessary. according to the local supplier, tin hang technology limited, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 june 2012.

Device

Captia™ Varicella-Zoster Virus IgG Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Trinity Biotech Captia™ Varicella-Zoster Virus IgG Kit
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech