Safety Alert for LifeScan OneTouch Ultra blood glucose meters

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

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
    2006-12-19
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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
    Dh closely monitoring safety of lifescan blood glucose meter the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company was following up whether the lifescan onetouch ultra blood glucose meters supplied to hong kong were of the same design and software as those available in united kingdom. a dh spokesman said that the unit of measurement of some meters of this model in united kingdom might change from mmol/l to mg/dl if the meter was dropped or if the battery was changed when the meter was switched on. the spokesman said, "as a precautionary measure, users of any brands of blood glucose meters should always check and ensure that the unit of measurement is in mmol/l in every test. if the unit of measurement is in mg/dl, they should immediately contact their suppliers." "members of the public are advised to follow strictly instructions in the manual when using blood glucose meters." the spokesman said that dh had informed the public and private hospitals, nursing homes, medical professional associations, and diabetes patient support groups about this safety issue. dh has not received any report of adverse events related to the unit of measurement issue, he added. relevant information has also been posted on the mdco website http://www.Mdco.Gov.Hk/english/recalls/recalls.Html . ends/tuesday, december 19, 2006 nnnn.

Device

  • Model / Serial
  • Product Description
    Press release: DH Closely Monitoring Safety of Lifescan Blood Glucose Meter
  • Manufacturer

Manufacturer