Events

Safety Alert for Mylife Pura blood glucose strips

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

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
    2012-02-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120223.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 mylife pura blood glucose strips in france the department of health (dh) today (february 22) drew the public's attention to the recall of certain lots of a blood glucose test strip in france. the affected product is mylife pura (box of 100) manufactured by bionime corporation. the test strips may give falsely high blood glucose readings. the dh was informed by the french medical device regulatory authority, agence francaise de sécurité sanitaire des produits de santé (afssaps), about the recall. according to afssaps, the problem came to their notice when several reports of overestimation of blood glucose levels were received. further investigation revealed that the problem was due to the accidental opening of the unsealed vials of the test strips during transportation from the distributor in france to the pharmacies. as the test strips are very sensitive to air exposure, they may lose performance and give falsely high readings. the manufacturer has since then taken preventive action by starting to seal all the vials with a protective film. a spokesman for the dh explained that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia - indeed, such a case has been reported in france. so far, the dh has not received any local report of adverse events arising from use of the product. although there is currently no readily available evidence to suggest that the affected product has ever been exported to hong kong, the dh is following up with the manufacturer to verify that this is indeed the case. meanwhile, as a precautionary measure, members of the public who may have the above product in their hands are advised to stop using any vials which came unsealed and surrender them to the dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai. "for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their health-care professionals for advice as soon as possible," the spokesman said. ends.

Device

Mylife Pura blood glucose strips
  • Model / Serial
  • Product Description
    Press release: Recall of Mylife Pura blood glucose strips in France
  • Manufacturer
    Bionime Corporation

Manufacturer

Bionime Corporation