International safety notice
It has been discovered that there is an error in the serial number written on the product nameplate for this product. (Incorrect) K006152203 (positive) K006152303 For this reason, we are conducting a voluntary recall in order to replace the product nameplates of the lots manufactured on the same day.
Japan / PMDA Recalls · JPN · Mar 10, 2023
Key facts
| Title | It has been discovered that there is an error in the serial number written on the product nameplate for this product. (Incorrect) K006152203 (positive) K006152303 For this reason, we are conducting a voluntary recall in order to replace the product nameplates of the lots manufactured on the same day. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: glycated hemoglobin analyzer Brand name: Glycohemoglobin analyzer A1c iGear Quick K |
| Manufacturer | Sakae Co., Ltd. |
| Models | K006132203, K006172203, K006122203, K006162203, K006082203, K006152203, K006092203, K006112203, K006142203, K006102203 |
| Date | Mar 10, 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