| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00368-1 |
| Product Name/Description |
Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)
ARTG Number: 173886 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Reports have been received that the Sysmex Haematology Analyser XN-Series may generate an intermittent inaccurate low Eosinophil count. Patient samples analysed by the XN-Series analyser reported 0% Eosinophils count, but on subsequent manual review, up to 11% Eosinophils were observed. This issue may lead to misdiagnosis or delay in treatment for conditions such as allergies or parasitic infections. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In order to detect the phenomenon, Roche is recommending users set up an Action comment or a Block Validate rule in the Rerun/Reflex/Comment Rule in the IPU settings when certain conditions are met. Users are advised that this action is currently undergoing validation and upon finalisation, a followup notification will be communicated to them. Users are also requested to discuss this matter with their Medical Director.
This action has been closed out on 22/01/2020 |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |