| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00828-1 |
| Product Name/Description |
Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)
Analysers with s/w version 00-13 and above that have product licence for Low WBC mode
ARTG Number: 173886 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics Australia has been informed by Sysmex Asia Pacific that potentially inaccurate WBC results could occur on the XN-L series analysers.
It was reported that the WBC results could be false low when the following steps are performed:
- The manual mode is selected
- Whole blood mode (Diluent or body fluid mode) is changed to Low WBC mode
- Measurement information is set with manual dialog and then closed by OK
- No measurement obtained with Low WBC mode and then the mode is changed to another measurement mode
- The next measurement WBC result becomes half of the correct WBC value
This issue may lead to incorrect diagnosis or treatment but this risk is mitigated when the clinical decision is made by considering the previous results, patient conditions and other test results. One complaint worldwide has been received (from Japan) relating to this issue. No such complaints to date have been received in Australia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche will be contacting users to arrange the installation of a software upgrade to version 00-16A as a permanent fix. For previously affected results, users should discuss with their Medical Director whether a look-back is required.
This action has been closed out on the 16/11/2018. |
| Contact Information |
02 9860 2357 - Roche Diagnostics |