International safety notice
According to the manufacturer, when measuring creatinine with the medical device, in rare cases, the patient's measurement result will be lower than the expected value. I was informed that there was a possibility. As a result of an investigation by an overseas manufacturer, it was determined that this phenomenon was caused by the creatinine membrane, and we have now confirmed that the cause of this phenomenon has been confirmed. We have received notification that the improvement of the creatinine membrane has been completed, so we will review the creatinine membrane before the improvement. We will carry out the collection. Regarding this event, we have already provided information to the relevant facilities and thoroughly informed them about preventive measures against this event. Masu.
Japan / PMDA Recalls · JPN · May 20, 2021
Key facts
| Title | According to the manufacturer, when measuring creatinine with the medical device, in rare cases, the patient's measurement result will be lower than the expected value. I was informed that there was a possibility. As a result of an investigation by an overseas manufacturer, it was determined that this phenomenon was caused by the creatinine membrane, and we have now confirmed that the cause of this phenomenon has been confirmed. We have received notification that the improvement of the creatinine membrane has been completed, so we will review the creatinine membrane before the improvement. We will carry out the collection. Regarding this event, we have already provided information to the relevant facilities and thoroughly informed them about preventive measures against this event. Masu. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: General purpose blood gas analyzer Sales name: ABL800 FLEX system |
| Manufacturer | Radiometer Co., Ltd. |
| Models | R0994, R0987, R0996, R0984, R1020, R0997, R1018, R1001, R1022, R0988, R0998, R1008 and 22 more |
| Date | May 20, 2021 |
| 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