(RTTNews) - Abbott Laboratories (ABT) has initiated a medical device correction in the United States for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring systems after internal testing found that some sensors may deliver incorrect low glucose readings.
The company said it has identified and resolved the issue, which was linked to one of the production lines manufacturing the sensors. Abbott added that it continues to produce Libre 3 and Libre 3 Plus sensors to support replacements and new orders, and it does not expect significant supply disruptions.
The action covers about 3 million sensors in the U.S., roughly half of which are estimated to have expired or already been used. Globally, Abbott has received 736 reports of severe adverse events and seven potentially related deaths.
Abbott advised consumers to visit www.FreeStyleCheck.com to determine whether their sensor is potentially affected. Impacted sensors will be replaced at no cost, and detailed instructions for checking devices and requesting replacements are available on the site.
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