Dive Brief:
- Abbott has recalled a small number of Freestyle Libre 3 sensors distributed in the U.S. in the first half of May, the company said Wednesday.
- Internal testing found a subset of three lots of the continuous glucose monitor (CGM) sensors may provide incorrect high glucose readings, the company said. The false readings could lead to incorrect treatment decisions, such as taking insulin when not required.
- Abbott is sending free replacements to affected users. A spokesperson for Abbott said via email the recall “may impact less than 1% of Libre 3 users in the U.S.” but did not specify the number of devices affected when asked.
Dive Insight:
Abbott’s Freestyle Libre 3 CGM product consists of a wearable sensor, a reader and an app. The recall affects only the sensor component. Abbott has “received a small number of reports from consumers regarding the issue,” the spokesperson wrote.
The company said it has identified the root cause and was “able to narrow the issue to a small subset of sensors.” It did not provide details on the cause or whether it has received reports of injuries linked to the fault.
Abbott is asking users to visit www.FreeStyleConfirm.com and enter the serial numbers of their sensors to check if their devices are affected. The company has told customers not to use any sensors covered by the recall. Users who are currently wearing an affected sensor should immediately remove the device.
Abbott said it has communicated with the Food and Drug Administration. The agency has not yet added the recall to its database. The database features earlier Abbott CGM recalls, including an action related to the Libre 3 app posted at the start of 2024 and a 2023 event about Libre 2 readers that could catch fire if improperly stored or charged.
