Safety Alert for LifeScan OneTouch SureStep blood glucose test strips with incorrect readings

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
    2010-02-12
  • 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
    Recall of lifescan onetouch surestep blood glucose test strips with incorrect readings the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company had initiated a voluntary recall of blood glucose test strip which may provide low readings. only one affected lot (lot number 2966727) of lifescan onetouch surestep test strips was supplied to hong kong. the affected test strips may provide low test results when the blood glucose level is greater than 22.2mmol/l, a dh spokesman said. "a total of 2,160 boxes of the lot have been imported to hong kong. among them, 2,116 unsold boxes have already been retrieved from the market. only 44 boxes have been sold in hong kong," the spokesman said. the dh has not received any report of adverse events arising from the test strip. members of the public should stop using the affected product and contact the company at hotline 3128 8101. it will operate daily from 9am to 6pm including the chinese new year holidays. the department will closely monitor the recall. ends/friday, february 12, 2010.

Device

  • Model / Serial
  • Product Description
    Press release: Recall of LifeScan OneTouch SureStep blood glucose test strips with incorrect readings
  • Manufacturer

Manufacturer