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MILPITAS, Calif. — LifeScan Inc. has begun a voluntary recall and replacement for all of its OneTouch VerioIQ blood glucose meters in the United States.
The Johnson & Johnson subsidiary said Monday that it has initiated the recall because at extremely high blood glucose levels — 1024 mg/dL and above — the meter won’t provide a warning that the blood glucose is extremely high and will shut off, potentially leading to incorrect treatment and delaying proper treatment.
To date, no adverse events or patient injuries related to this specific issue have been reported for the OneTouch VerioIQ Meter, the company said.
LifeScan said the likelihood of experiencing a very high blood glucose level of 1024 mg/dL or higher is remote, though such a reading indicates a serious health risk and warrants immediate medical attention.
Patients who are using the OneTouch VerioIQ Meter are advised to contact LifeScan customer service to order a replacement meter at no charge and to speak with a LifeScan representative.
The company said patients may continue to test with their OneTouch VerioIQ Meters while they wait for their replacement meter to arrive as long as they are aware of this issue.
"Our patients’ safety is our number one priority," stated Michael Pfeifer, LifeScan’s chief medical officer. "When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. 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."
Notifications are being sent to all registered users, health care professionals, pharmacies and distributors wherever these products are sold. LifeScan estimates that there are about 90,000 active OneTouch VerioIQ Meter users in the United States.
The company said it’s in the process of implementing an update to the meter to address the issue.
All other OneTouch blood glucose brands sold in the United States, including OneTouch Ultra Meters, OneTouch Select Meters and OneTouch Verio Test Strips, aren’t affected, LifeScan said.
LifeScan said that outside the United States, the recall affects three Verio blood glucose meters from OneTouch: the OneTouch VerioIQ, OneTouch VerioPro and OneTouch VerioPro+ brands.
According to the company, to date no adverse events or patient injuries related to this issue have been reported globally for the OneTouch VerioIQ and OneTouch Verio®Pro+ meters. For the OneTouch VerioPro Meter, LifeScan has received one report of a serious adverse event, which occurred outside the United States. The company said it hasn’t determined whether the OneTouch VerioPro Meter was a causal factor.
LifeScan added that it has notified the Food and Drug Administration and health care authorities around the world of the voluntary recall.
