Health Canada Issues Recall for Glucose Monitors Due to Risks

Health Canada is urging diabetes patients to verify whether their glucose monitors are part of an international recall due to serious health risks. The federal agency has announced a recall for certain FreeStyle Libre 3 Plus sensors that may deliver inaccurate glucose readings.

According to Health Canada, a subset of these sensors may provide incorrect low glucose readings. If these inaccuracies go unnoticed, they could lead to improper treatment decisions for individuals managing diabetes. "If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes," the agency stated in its recall notice.

The recall highlights that erroneous readings could mislead users into thinking their glucose levels are low. This misunderstanding may result in excessive carbohydrate consumption or delays in insulin administration, which can pose serious health risks, including potential injury or death.

The FreeStyle Libre sensors measure glucose levels in interstitial fluid just beneath the skin and transmit the data wirelessly to a device or smartphone. Abbott Diabetes Care, the manufacturer of these devices, reported that the affected products are potentially linked to seven deaths and over 700 injuries globally. However, an Abbott spokesperson declined to disclose the specific countries where these incidents occurred.

Health Canada has advised users to stop using the affected sensors, dispose of them, and request replacements. The model and serial numbers for the recalled products can be found on Health Canada’s recall website.

Additionally, another model, the FreeStyle Libre 3, has been recalled in other countries, including the United States, but Abbott confirmed that it is not under recall in Canada. The company stated that it has identified and resolved the production line issue that led to the inaccuracies. Health Canada is expected to provide further responses but was unable to answer questions by the deadline.