International safety notice
Common name: Immunoluminescence measurement device Brand name: (1) Access Immunoassay Analyzer (2) Access2 immunoassay system (3) Access2 Immunoassay System PRO (4) Unicell DxI800 system
Japan / PMDA Recalls · JPN · May 12, 2023
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common name: Immunoluminescence measurement device Brand name: (1) Access Immunoassay Analyzer (2) Access2 immunoassay system (3) Access2 Immunoassay System PRO (4) Unicell DxI800 system |
| Manufacturer | Beckman Coulter Co., Ltd. |
| Models | 602379, 510262, 602329, 506367, 602544, 572752, 509603, 603776, 506315, 607837, 573008, 571877 and 128 more |
| Date | May 12, 2023 |
| 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