SENS - Abbott recalls millions of FreeStyle Libre glucose monitoring devices

April, 06 2023 05:02 PM Senseonics Holdings Inc.

2023-04-06 17:02:12 ET

The FDA on Thursday classified a recent product recall announced by Abbott Laboratories ( NYSE: ABT ) for millions of its FreeStyle Libre glucose monitoring systems as a Class I recall, the most serious type.
The agency said that Abbott ( ABT ) began the product recall in February for more than four million devices distributed between Nov. 2017 – Feb. 2023 due to an issue related to the systems' reader devices.
The FDA said the company recalled the products due to the risk of extreme heat and fire reader in systems' reader devices, which use rechargeable lithium-ion batteries.
The company has reported 206 incidents related to the issue , including seven fires and one injury. There were no deaths due to the defect.
In March, the company announced FDA clearance to integrate its FreeStyle Libre 2 and FreeStyle Libre 3 continuous glucose monitoring (CGM) systems with automated insulin delivery (AID) systems.
ABT competes with DexCom ( DXCM ), Medtronic ( MDT ), Roche ( OTCQX:RHHBY ), and Senseonics ( SENS ) in the CGM market, expected to reach $32B by 2031, according to Allied Market Research.

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