Recall Z-2414-2023 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Abbott Diabetes Care, Inc.
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
| Date | Aug 17, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Software Design Change |
| Action | On 7/12/23, correction notices were e-mailed or mailed to customers and distributors who were asked to do the following: If the "Incompatible Sensor" message is received when applying a new sensor and attempting it to start it with the Reader, follow these steps below. If previous Sensor retained: a) Wait 3 hours before scanning the previous sensor. While waiting, please use a blood glucose meter to check glucose. b) "Replace Sensor" should appear. c) Scan the new Sensor and "New Sensor Starting Up" screen should appear. If previous Sensor not retained: a) Users can use the free FreeStyle L |
| Quantity | 1,722,645 |
| Distribution | US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc., Jun 12, 2020 |