| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01062-1 |
| Product Name/Description |
CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
Multiple Siemens Material Numbers and Date Codes affected
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received customer complaints regarding damage to the external power supply adaptors that accompany the CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect urine analysers, which can result in an increased potential for electric shock to the user. This also includes orderable spare parts. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the power supply adaptor is embossed with one of the affected date codes, immediately discontinue use and discard the power supply adaptor. If your power supply adaptor does not have an affected date code, but the case is cracked or damaged in any way, immediately discontinue use and discard the power supply adaptor. This action has been closed-out on 07/06/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |