International safety notice
General name: Enzyme immunoassay device Brand name: (1) Fully automatic immunoassay device HISCL-5000 (2) Fully automatic immunoassay device HISCL-800
Japan / PMDA Recalls · JPN · Sep 12, 2024
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Enzyme immunoassay device Brand name: (1) Fully automatic immunoassay device HISCL-5000 (2) Fully automatic immunoassay device HISCL-800 |
| Manufacturer | Sysmex Corporation |
| Models | 11436, 11708, ＨＩＳＣＬ‐５０００, 11384, 11362, ＨＩＳＣＬ‐８００, 11704, 11412, 11078, 11359, 11787, 11635 |
| Date | Sep 12, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers 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