LifeScan, Inc. is initiating
a voluntary recall and replacement for all of its OneTouch® Verio®IQ blood
glucose meters in the United States, effective immediately.
LifeScan is recalling and replacing all OneTouch® Verio®IQ Meters because at
extremely high blood glucose levels of 1024 mg/dL and above, the meter will
not provide a warning that the blood glucose is extremely high and will shut
off, thereby potentially leading to incorrect treatment and delaying proper
treatment.
The likelihood of experiencing an extremely high blood glucose level of 1024
mg/dL or higher is remote; however, when such a blood glucose level occurs, it
is a serious health risk requiring immediate medical attention. Because these
products do not provide an appropriate warning at glucose levels of 1024 mg/dL
or higher, diagnosis and treatment of extreme hyperglycemia may be delayed or
incorrect treatment may be given resulting in potentially serious health risk
or fatality.
Patients who are using the OneTouch® Verio®IQ Meter should:
o Contact LifeScan Customer Service at (800) 717-0276 to make arrangements
to receive a replacement meter at no charge and to speak with a LifeScan
representative. Representatives are available 8 a.m. to 10 p.m. EDT Monday
through Sunday (LifeScan U.S. Customer Service).
o Seek additional information about this recall on www.onetouch.com.
o Please note that patients may continue to test with their OneTouch®
Verio®IQ Meters while they wait for their replacement meter to arrive as
long as they are aware of this issue. However, LifeScan advises that if
the meter unexpectedly turns itself off during testing, this could be a
sign of extreme hyperglycemia requiring immediate medical attention and
the patient should call a healthcare professional.
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