FDA-Device2023-08-23Class II
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Abbott Diabetes Care, Inc.
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
Sold states
US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.
Affected count
1,722,645
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Products
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2414-2023Don't want to check this manually?
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