International safety notice
After an investigation at an overseas manufacturer, Abbott Japan LLC found that some FreeStyle Libre sensors were found to have incorrectly high We have confirmed that it may indicate a course value. Due to the risk of health damage, we have decided to voluntarily recall the affected products. To determine if other sensor lots are affected, additional We conducted an evaluation. I have confirmed that only one is affected. The cause has been determined to be incorrect calibration at an overseas sensor manufacturing factory. Therefore, we added a screening test to the shipping inspection at the factory.
Japan / PMDA Recalls · JPN · Mar 3, 2023
Key facts
| Title | After an investigation at an overseas manufacturer, Abbott Japan LLC found that some FreeStyle Libre sensors were found to have incorrectly high We have confirmed that it may indicate a course value. Due to the risk of health damage, we have decided to voluntarily recall the affected products. To determine if other sensor lots are affected, additional We conducted an evaluation. I have confirmed that only one is affected. The cause has been determined to be incorrect calibration at an overseas sensor manufacturing factory. Therefore, we added a screening test to the shipping inspection at the factory. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Glucose Monitor System Sales name: FreeStyle Libre |
| Manufacturer | Abbott Japan LLC |
| Models | 0M000NKZYYR, 0M000NVM8M0, 0M000NWQUW8, 0M000NQG23D, 0M000NQFDZH, 0M000NQG1G8, 0M000NVFU70, 0M000NQ3Y9W, 0M000NQG9C8, 0M000NQGDA4, 0M000NKYLNW, 0M000NVFZ3D and 7561 more |
| Date | Mar 3, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1