Recall Z-2414-2023— Abbott Diabetes Care, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Diabetes Care, Inc., initiated 2023-07-12. It names one FDA 510(k) clearance: K193371. Product: FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System. Reason: 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.
- Recalling firm
- Abbott Diabetes Care, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-12
- Firm location
- Alameda, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.