Events

Safety Alert for Captia Malaria EIA 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
    2016-07-25
  • Event Date Posted
    2016-07-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160725a.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 malaria eia kit medical device manufacturer, trinity biotech, has issued a medical device safety alert concerning its captia malaria eia kit [product code: 2322470; lot number: 011] while conducting a review of the labeling for the above mentioned kit as part of an investigation, the manufacturer discovered that an incorrect expiration date was assigned to the abovementioned kit lot number. the tmb substrate solution (lot number 523759-506036) that was included in this kit has an expiration date of november 2016. this component expiration should have been considered during the expiration date assignment of this kit lot and therefore the kit has an expiration date of november 2016 and not june 2017 as currently labeled. as the tmb in this kit is still within expiry date, no look back or result review is required on previously release results. according to the manufacturer, 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 25 july 2016.

Device

Captia Malaria EIA Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Trinity Biotech Captia Malaria EIA Kit
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech