FDA recall Z-2414-2023

Abbott Diabetes Care, Inc. · Class II · device

Product

FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

Reason for recall

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

Distribution

US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.

Key facts

Status
Ongoing
Initiation date
2023-07-12
Report date
2023-08-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alameda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2414-2023