A massive recall of glucose sensors is currently underway across Canada and 16 other countries, prompted by safety concerns linked to seven fatalities. This information was announced on Wednesday by Abbott, the pharmaceutical company responsible for the affected devices.
Details of the Recall
The recall impacts specific models of FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose sensors, which are widely used by diabetic patients for continuous glucose monitoring. Abbott disclosed that internal tests revealed that some of these sensors may report incorrectly low blood glucose levels.
Incidents Reported
- Seven reported deaths.
- 736 serious incidents potentially linked to sensor malfunction.
The malfunctioning devices have been associated with a particular production line. Abbott has notified health authorities in all countries where these sensors have been sold and has initiated the recall process.
Distribution and Recommendations
In the United States alone, it is estimated that around 3 million defective sensors have been distributed. In Canada, the Canadian Food Inspection Agency (CFIA) has issued a recall notice urging users to check the serial numbers of their FreeStyle Libre® 3 sensors.
What Users Should Do
Canadian users should visit www.freestylecheck.com to determine whether their sensor is part of the recall. If it is, they are advised to:
- Cease using the faulty sensor immediately.
- Dispose of the device properly.
- Request a replacement from Abbott.
Countries Involved
The recall affects the following countries:
- Canada
- United States
- France
- Germany
- Austria
- Belgium
- Denmark
- Spain
- Finland
- Italy
- Luxembourg
- Netherlands
- New Zealand
- Norway
- Sweden
- Switzerland
- United Kingdom
This extensive recall underscores the importance of safety in medical devices, especially those critical for managing chronic conditions like diabetes. Users should remain vigilant and follow the recommendations provided by health authorities and Abbott.
