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Abbott Diabetes Care, Inc. recalls FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Recalled August 23, 2023 · FDA recall Z-2414-2023 · Abbott Diabetes Care
Hazard
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results · FDA Class II
Units
1,722,645
Sold at
US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.
Description
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
Product
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Manufacturer(s)
Abbott Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →