International safety notice
The item to be collected this time is the electrolyte K electrode comprised in the main unit. Target devices are BM1650, BM2250, BM6010, BM6050, BM6070, BM8020, BM8030, BM8040, BM8060, BM9030, Electrolyte unit installed in BM9130/ZS050. For the K electrode with the applicable target serial number, the urine mode carrier was changed after being replaced for maintenance by multiple customers. In bration measurement, safety issues such as invalid ISE test results and invalid electrolyte test results only for K item occur. We were informed that the urine mode could not be measured, and as a result of internal verification, it was discovered that there was a problem with a specific serial number. Did. As a response to this issue, we will be collecting the K electrodes with the relevant serial numbers.
Japan / PMDA Recalls · JPN · Jul 10, 2023
Key facts
| Title | The item to be collected this time is the electrolyte K electrode comprised in the main unit. Target devices are BM1650, BM2250, BM6010, BM6050, BM6070, BM8020, BM8030, BM8040, BM8060, BM9030, Electrolyte unit installed in BM9130/ZS050. For the K electrode with the applicable target serial number, the urine mode carrier was changed after being replaced for maintenance by multiple customers. In bration measurement, safety issues such as invalid ISE test results and invalid electrolyte test results only for K item occur. We were informed that the urine mode could not be measured, and as a result of internal verification, it was discovered that there was a problem with a specific serial number. Did. As a response to this issue, we will be collecting the K electrodes with the relevant serial numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Discrete clinical chemistry automatic analyzer Brand name: (1) JCA-ZS series automatic analyzer Cleanerizer (2) JCA-BM series automatic analyzer Cleanerizer |
| Manufacturer | JEOL Ltd. |
| Models | BM8030, BM8060, BM8020, BM6050, BM8040, BM1650, ZS050, BM9030, 85084, BM6010, BM6070, 85537 and 2 more |
| Date | Jul 10, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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