Health Canada Recalls Glucose Monitors Over Potentially Incorrect Readings

Health Canada has issued a recall for some FreeStyle Libre 3 Plus Sensors over concerns of incorrect glucose readings. Abbott Diabetes Care handout photo

Health Canada is recalling some glucose monitors it says could give incorrect readings, causing health problems for those with diabetes.

The agency says the international recall includes FreeStyle Libre 3 Plus Sensors with serial numbers T60003522 and T60003216, and model number 78791-01.

Health Canada says the monitors can provide incorrect low glucose readings, which can impact a person’s health. It noted that people may make “incorrect treatment decisions” such as taking in too many carbohydrates or skipping or delaying insulin doses.

The agency said such decisions “pose serious health risks” such as injury or death.

It recommends users check the serial number on their device to see if they have a model that is part of the recall. For those who have a monitor that has been recalled, the agency advises to “immediately discontinue use,” dispose of the device, and request a replacement.

The monitors were sold by Abbott Diabetes Care Ltd., which said it will replace the device for free.

Health Canada recommends that consumers check if their monitors are part of the recall at www.FreeStyleCheck.com, where instructions are available on how to check sensors and how to request a replacement.

The company said in a Nov. 24 news release that it identified and resolved the issue, which related to one production line of several that make the sensors.

Abbott noted there have been 736 severe adverse events, with 57 of those in the United States, and seven deaths that are potentially associated with the issue.

The recall does not include FreeStyle Libre 3 readers and mobile apps, according to the company. The FreeStyle device measures glucose through a small sensor worn on the back of the upper arm that sends the glucose data to an accompanying smartphone app.

The recall comes about five months after a similar recall for Contour brand glucose monitors.

In that instance, Health Canada said the 33 Contour Net Gen blood glucose monitoring systems were displaying incorrect units of measure of glucose, which could result in “misinterpretation of glucose levels.”

The devices were distributed from Feb. 25 to April 21, according to the recall, which impacted model number 79232 and lot numbers PH25010004, PH24110008, PH25010003, PH24110007, and PH24110009.

Health Canada has also issued an advisory for those who use an app to track glucose levels. It noted that some patients have not received or heard safety alerts from their devices.

“If you miss a safety alert, you may fail to treat your low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), which could cause serious health issues requiring medical treatment, such as severely high or low blood sugar, loss of consciousness, seizure, coma and death,” the agency said in a March notice on its website.

It advised Canadians to check their settings and volume levels on the device with the app.

It also said that those who feel unwell should check glucose levels with a continuous glucose monitor or alternative method.