| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00112-1 |
| Product Name/Description |
Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).
Sysmex CS-2000i
Siemens Material Number: 10488064
Sysmex CS-2100i
Siemens Material Number: 10488062
Sysmex CS-2500
Siemens Material Number: 11239235
Sysmex CS-5100
Siemens Material Number: 10709128
ARTG Number: 179939 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that under very rare circumstances a false negative result may be reportable. The issue may only occur under the following conditions:
- the initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution; and
- the raw signal that is generated from the reanalysis is below the Limit of Blank (LoB) of the method.
Under such conditions the low reanalysis raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. This raw value is corrected by the dilution factor and can then be incorrectly calculated from the calibration curve as a falsely low result. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising customers that the threshold for “Min Range” of the extrapolation needs to be changed within the Innovance D-Dimer assay setting on the Sysmex system as follows:
- In the CS software, Select “Menu”
- Select “Settings”
- Select “Assay Group Settings”
- Select “Innovance D-dimer” assay
- Double click assay parameter “INN DDi”
- Under the “Calculation Method” tab, change the current “Extrapolation” threshold for the “Min” extrapolation range from 0.01 to the new threshold of 1.00
- Select “Save” and restart CS-System software
After the restart, the system will work with the new setting.
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 28/11/2019 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |