Healthcare giant Abbott has launched a major international recall of its FreeStyle Libre 3 and Libre 3 Plus blood glucose sensors, warning that defective devices giving inaccurate readings may be linked to seven deaths and hundreds of serious injuries.
Global Recall Affects Millions of Diabetics
The urgent safety action spans more than a dozen countries, including the United Kingdom. Abbott confirmed the recall this week after identifying a critical fault in sensors produced on a single manufacturing line.
Approximately 3 million of the defective sensors were distributed in the United States, with millions more sold across Europe, including in the UK, and in other nations like Canada and New Zealand. The affected countries are Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, the Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland and the United Kingdom.
Life-Threatening Risks of Inaccurate Readings
For the roughly 2.5 million people in the US who use continuous glucose monitors, and millions more globally, accurate readings are vital for daily safety. The recalled sensors were found to give falsely low glucose readings.
This fault poses a direct and severe danger. If a diabetic receives an incorrectly low reading, they might take more insulin than needed, causing a dangerous plunge into hypoglycemia. Conversely, a falsely high reading could lead someone to miss a genuine and dangerous low blood sugar episode.
Failure to treat true high blood sugar can also allow levels to rise into the danger zone, risking diabetic ketoacidosis, a life-threatening complication.
Abbott has received reports of 736 serious health incidents tied to the fault, including 57 in the US, alongside the seven tragic fatalities. The company has not detailed the specific nature of all injuries suffered.
What Users Need to Do Now
The US Food and Drug Administration (FDA) and Abbott have advised anyone with an impacted device to stop using it immediately. The affected products can be identified by their model numbers and unique device identifiers:
- FreeStyle Libre 3 sensors: Model numbers 72081-01 and 72080-01. Unique Device Identifiers 00357599818005 and 00357599819002.
- FreeStyle Libre 3 Plus sensors: Model numbers 78768-01 and 78769-01. Unique Device Identifiers 00357599844011 and 00357599843014.
Abbott stated it has identified and resolved the root cause of the manufacturing issue. The company insists it can continue to produce sensors to fulfil replacement and new orders without significant supply disruption.
This recall underscores the critical reliance of diabetics on monitoring technology and the potentially catastrophic consequences when such devices fail. Users of the FreeStyle Libre 3 system are urged to check their sensor details without delay.
