A line of blood glucose meters that are used by people with diabetes are being recalled because the devices turn off when a high blood glucose level of 1,024 mg/dL and above is detected.
LifeScan, Inc., a company under the umbrella of Johnson & Johnson, produces the device named the OneTouch VerioIQ Meter and has now initiated a voluntary recall and replacement for all of the devices in the United States.
"LifeScan is recalling and replacing all OneTouch VerioIQ Meters because at extremely high blood glucose levels of 1,024 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 company said in a press release.
The company also said that while an extremely high blood glucose level is extremely rare, it still poses a very serious health risk that requires emergency medical attention.
No injuries or "adverse events" have a occurred as a result of the faulty blood glucose meters, according to the release.
"Our patients' safety is our number one priority," said Dr. Michael Pfeifer, Chief Medical Officer for LifeScan.
"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 the best interest of our patients."
LifeScan estimates that there are about 90,000 active OneTouch VerioIQ Meters in the U.S. and said that notifications are being sent out to all registered users, healthcare professionals, pharmacies and distributors of the device.
Anyone with a device affected by the recall is urged to contact LifeScan customer service at (800) 717-0276 and to continue using his or her meter until a new one is sent.
But users should still be aware that if the device shuts off after a reading, it may indicate extreme hypoglycemia that requires immediate medical attention.
READ THE FULL RECALL STATEMENT HERE
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