Recall Z-1275-2023 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Abbott Diabetes Care, Inc.
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
| Date | Apr 6, 2023 (initiated Feb 13, 2023) |
| Status | Open, Classified |
| Reason | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use. |
| Root cause | Device Design |
| Action | On 02/13/2023, correction notices were mailed or emailed to customers, health care professionals, and distribution partners who were asked to do the following: To determine if the Reader needs to be replaced, answer these questions: Does Reader appear damaged, cracked, or swollen? Has Reader been too hot to hold? Is it no longer able to hold a charge? If NO to all, perform a Reader Test. See www.FreeStyleBattery.com If yes or if the test failed, discontinue use and call Customer Service for replacement. - Don't expose the Reader, power adapter or yellow USB cable to liquids. - Store the Read |
| Quantity | 1,534,532 |
| Distribution | U.S. Nationwide. |
| 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 |