(Corrects headline, first paragraph to nearly 2 million, from
* Meters fail to warn of extremely high glucose levels
* Health regulators, patients notified of recall
* OneTouch Verio IQ, Verio Pro and Verio Pro+ affected
March 25 Johnson & Johnson is recalling
and replacing nearly 2 million meters used to measure blood
glucose levels in diabetics due to a failure to operate properly
at extremely high glucose readings, the company's LifeScan unit
said on Monday.
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.
At extremely high glucose readings of 1024 mg/dl and above,
the units have failed to provide a warning of dangerously high
blood sugar and will shut off, potentially delaying proper
treatment, the company said.
LifeScan said it has notified the U.S. Food and Drug
Administration and other health regulators of the voluntary
recall, as well as registered users and healthcare
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
(Reporting by Bill Berkrot; editing by John Wallace)