| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00426-1 |
| Product Name/Description |
Berichrom Protein C on Sysmex CA-1500, CA-7000, CS-2000i and CS-5100 instruments. An in vitro diagnostic medical device (IVD).
Berichrom Protein C Catalogue Numbers: 10446499 and 10446500
Lot Numbers: 45059 and subsequent, 44851 also affected
ARTG Number: 178559 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
The affected Berichrom Protein C product lots may lead to a failure of calibration on the above Sysmex instruments, where the calibration curve is indicated as invalid due to the 0% point of the calibration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens advises that in case the Berichrom Protein C calibration curve on your system is indicated as being invalid due to the 0% calibration point the mentioned calibration point has to be set manually to “0” dOD.
Update July 2018: Siemens has released a new Protocol Disc Version with revised assay applications on Sysmex CS-2000i, CS-2100i, CS-2500 and CS5100 systems to resolve this issue. Siemens will implement the respective applications to analysers during the next service visit. An updated application sheet will also be provided to users.
This action has been closed out on 24/09/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |