Events

Safety Alert for i-sens Model CareSens II

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

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
    2009-04-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20090424.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
    Press release
  • Reason
    Recall of blood glucose meters with incorrect readings (i-sens model caresens ii) the department of health today (april 23) alerted the public and the medical sector, of a voluntary recall of a type of blood glucose meter (bgm)which displayed falsely low readings. dh immediately looked into the case upon receiving notification from an informant that two bgm manufactured by i-sens inc, were found to display falsely low readings. it was revealed that only one specific lot (lot no. isp11e02101 – isp11e02600) of the bgm was affected. the manufacturer, i-sens inc, has initiated a voluntary recall through its distributor, bioscan ltd. according to bioscan ltd, there were 150 bgm of the affected lot imported to hong kong and 106 bgm to macao respectively. dh has notified the health bureau of macao of the recall. users should not use the blood glucose meters of the affected lot and seek advice from their doctors. the department has not received any report of adverse events arising from this issue. dh will closely monitor the recall. the spokesman said people using the meters concerned should contact the company by calling its hotline (3589 6670) during office hours for replacement. ends/thursday, april 23, 2009.

Device

i-sens Model CareSens II
  • Model / Serial
  • Product Description
    Press release: Voluntary Recall of blood glucose meters with incorrect readings (i-sens Model CareSens II)
  • Manufacturer
    i-SENS Inc

Manufacturer

i-SENS Inc