| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00137-1 |
| Product Name/Description |
VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers
Catalogue Number: 10380063
Siemens Reference Number: IMS 14-01
ARTG Number: 174383 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for incorrect results to be reported when the VersaCell system drops a sample tube during transfer to the IMMULITE 2000/IMMULITE 2000 XPi automation rack under certain specific conditions. This issue only occurs with VersaCell systems that are connected to IMMULITE 2000/2000XPi and does not affect any other analysers that interface with the VersaCell system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing additional instructions to mitigate the occurrence of incorrect results due to dropped tubes. Investigations into the issue are continuing and customers will be alerted once a solution has been developed. This action has been closed-out on 04/04/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |