International safety notice
Common names: (1)-(4) Discrete clinical chemistry automatic analyzer, (5) Immunoluminescence analyzer, (6) Dry clinical chemistry analyzer chemical analysis device Sales name: (1) Vitros XT7600 (2) Vitros 5600II (3) Vitros 5600 (4) Bitros 4600 (5) Bitros 3600 (6) Vitros XT3400
Japan / PMDA Recalls · JPN · Aug 29, 2023
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common names: (1)-(4) Discrete clinical chemistry automatic analyzer, (5) Immunoluminescence analyzer, (6) Dry clinical chemistry analyzer chemical analysis device Sales name: (1) Vitros XT7600 (2) Vitros 5600II (3) Vitros 5600 (4) Bitros 4600 (5) Bitros 3600 (6) Vitros XT3400 |
| Manufacturer | Ortho Clinical Diagnostics Co., Ltd. |
| Models | 56001972, 34500608, 76001252, 34500545, 34500616, 56002073, 46000517, 76000950, 36001335, 46000529, 56003175, 46001168 and 210 more |
| Date | Aug 29, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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