[Recalled] The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. — There is a potential for
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. |
|---|---|
| Brand / manufacturer | Sysmex Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1945-2016 |
| Country of notice | Japan |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 December 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
This Class II recall concerns device products distributed in Japan and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.