| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00151-1 |
| Product Name/Description |
Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). An in vitro diagnostic medical device (IVD)
Siemens Catalogue & Material Numbers: OUHP295 / 10446442 & OUHP495 / 10446445
Sysmex Japan Catalogue & Material Numbers: OUHP295J / 10469932 & OUHP495J / 10469933
ARTG Numbers: 178501 & 179939 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens investigations have confirmed that with Sysmex CS-2000i or Sysmex CS-2100i Systems the last (up to 4) measurements out of a Thromborel S vial may be erroneously prolonged (longer PT sec, lowered % of Norm, increased INR). This may occur if the reagent in the vial is nearly used up and has been placed on board of the Sysmex CS-2000i/CS-2001i Systems for more than 4 hours. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are being advised to mix reagent carefully every 4 hours. Review of patient results should be carried out at the discretion of the laboratory director. Siemens representative will contact the affected customers as soon as a technical solution is available. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |