FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Reported: August 23, 2023 Initiated: July 12, 2023 #Z-2414-2023
Product Description
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
Details
- Recalling Firm
- Abbott Diabetes Care, Inc.
- Units Affected
- 1,722,645
- Distribution
- US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.
- Location
- Alameda, CA
Frequently Asked Questions
What product was recalled? ▼
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System. Recalled by Abbott Diabetes Care, Inc.. Units affected: 1,722,645.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 23, 2023. Severity: Moderate. Recall number: Z-2414-2023.
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