International safety notice
We received a complaint about the affected lot and conducted an investigation, which revealed that plasma samples separated using the affected lot were An event has been confirmed in which the measured plasma calcium concentration is 6 to 19% lower than the measured value of centrifuged plasma samples, etc. We are implementing a voluntary recall.
Japan / PMDA Recalls · JPN · Aug 27, 2024
Key facts
| Title | We received a complaint about the affected lot and conducted an investigation, which revealed that plasma samples separated using the affected lot were An event has been confirmed in which the measured plasma calcium concentration is 6 to 19% lower than the measured value of centrifuged plasma samples, etc. We are implementing a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Dry clinical chemistry analysis device Sales name: Fuji Dry-Chem NX600 accessories (Fuji Dry-Chem Plasma Filter PF) |
| Manufacturer | Fujifilm Co., Ltd. |
| Models | 640409, 540405, 740610, 740531, 640513, 640502, 540328, 640418, 740524, 640521, 640426, 440216 and 2 more |
| Date | Aug 27, 2024 |
| 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