Diabetes

Updated 17 November 2016

1.2 million blood glucose meters recalled

In the United States, about 90 000 OneTouch Verio IQ meters are affected out of some 1.2 million units of that model being recalled worldwide, the company said.

0

At extremely high glucose readings of 1024 mg/dl and above, the units have failed to provide a warning of dangerously high blood sugar levels and will shut off, potentially delaying proper diabetes treatment, the company said.

Recommendations from the FDA

LifeScan said it has notified the US Food and Drug Administration and other health regulators of the voluntary recall, as well as registered users and healthcare professionals. In addition to the Verio IQ model, J&J is also recalling about 670 000 of its OneTouch Verio Pro meters in Europe and 4 900 of its hospital-based OneTouch Verio Pro+ meters in the Middle East, Europe and the Asia/Pacific region.

No patient injuries have been reported in the United States related to the malfunction, the company said. LifeScan said there was one report of a serious adverse event outside the United States, but a link to the malfunctioning glucose meter had not been determined."We regret the inconvenience these actions may cause.

However, we will always err on the side of caution and make a decision that is in the best interest of our patients," Michael Pfeifer, LifeScan's chief medical officer, said in a statement.

The company said its OneTouch Ultra model was not affected by the recall. It said patients could continue to use the Verio IQ model until replacements arrive as long as they are aware that if the unit shuts down it could be indicative of dangerously high glucose levels.

 

Read Health24’s Comments Policy

Comment on this story
0 comments
Comments have been closed for this article.

Ask the Expert

Diabetes expert

Dr. May currently works as a fulltime endocrinologist and has been in private practice since 2004. He has a variety of interests, predominantly obesity and diabetes, but also sees patients with osteoporosis, thyroid disorders, men's health disorders, pituitary and adrenal disorders, polycystic ovaries, and disorders of growth. He is a leading member of several obesity and diabetes societies and runs a trial centre for new drugs.

Still have a question?

Get free advice from our panel of experts

The information provided does not constitute a diagnosis of your condition. You should consult a medical practitioner or other appropriate health care professional for a physical exmanication, diagnosis and formal advice. Health24 and the expert accept no responsibility or liability for any damage or personal harm you may suffer resulting from making use of this content.

* You must accept our condition

Forum Rules