Thursday, Abbott Laboratories (NYSE:ABT) said it is recalling some FreeStyle Libre 3 sensors after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings.
The use of the affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia), which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage, and death.
There have been two reported injuries. There have been no reports of death.
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This recall involves removing certain devices from where they are used or sold and does not apply to the FreeStyle Libre 3 reader or app.
The FreeStyle Libre 3 Continuous Glucose Monitoring System is intended to monitor glucose levels continuously. It helps people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. It is indicated for single-patient use and requires a prescription.
In July, Abbott sent all affected customers an Urgent Medical Device Recall recommending discontinuing the use, disposing of any affected sensors, and requesting a replacement.
Concurrently, on Thursday, Abbott announced the U.S. availability of Lingo, the company's first continuous glucose monitoring system, without a prescription.
The Lingo system includes a biosensor and a mobile app designed for consumers who want to improve their overall health and wellness.
Lingo is based on Abbott's FreeStyle Libre continuous glucose monitoring technology.
Abbott's consumer biowearable, Lingo, is available for consumers 18 years and older not on insulin. Lingo tracks glucose in real-time and provides personal insights and coaching to help people build healthy habits, retrain their metabolism, and improve their overall well-being.
Price Action: ABT stock is down 0.82% at $113.46 at last check Thursday.
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