International safety notice
An internal investigation revealed that the package insert for the product contained incorrect information. Therefore, we have decided to voluntarily recall the target devices that come with this package insert.
Japan / PMDA Recalls · JPN · Sep 17, 2024
Key facts
| Title | An internal investigation revealed that the package insert for the product contained incorrect information. Therefore, we have decided to voluntarily recall the target devices that come with this package insert. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Mobile discrete clinical chemistry automatic analyzer Sales name: Biolis 30i |
| Manufacturer | Tokyo Boeki Medisys Co., Ltd. |
| Models | 6016110624, 6016010624, 6015990624, 6016320724, 6016570824, 6016000624, 6016330724, 6015980524, 6016130624, 6016580824, 6016590824, 6016090624 and 7 more |
| Date | Sep 17, 2024 |
| 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