ADEA update: Abbott FreeStyle Libre 3 recall
- ADEA
- Feb 10
- 1 min read
No Abbott sensors distributed in Australia have been impacted by the recent recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitor sensors due to incorrect low glucose readings, an Abbott spokesperson has confirmed to ADEA.
The U.S. Food and Drug Administration (FDA) classified the recall as Class I, defined as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death".
"If undetected, these incorrect (lower than actual) glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses," the FDA states.
"These decisions may pose serious health risks, including potential injury or death, or other less serious complications."
On 9 February, an Abbott spokesperson confirmed to ADEA that "no Abbott sensors distributed in Australia are impacted by the recall".
Media reports state that the company has identified and resolved the cause of the issue, which relates to one production line among several that manufacture Libre 3 and Libre 3 Plus sensors.
Should you or your clients have any questions or require support, please call Abbott's Customer Care team on 1800 801 478 (8 pm–7 pm AEST, Monday–Friday, excluding public holidays).
