International safety notice
An abnormality was found in the optical calibration parameters of this product. It was confirmed that samples with a concentration of less than 8 g/dL could be measured, and the measurement results of glycated hemoglobin (HbA1c) could be incorrect. I got it. We will carry out.
Japan / PMDA Recalls · JPN · Aug 24, 2023
Key facts
| Title | An abnormality was found in the optical calibration parameters of this product. It was confirmed that samples with a concentration of less than 8 g/dL could be measured, and the measurement results of glycated hemoglobin (HbA1c) could be incorrect. I got it. We will carry out. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pack-type clinical chemistry analyzer Sales name: Eye Gear Pro (K) |
| Manufacturer | Sakae Co., Ltd. |
| Models | K000722307, K000742307 |
| Date | Aug 24, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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