| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00904-1 |
| Product Name/Description |
Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (An in vitro diagnostic medical device (IVD))
Catalogue Number: OWLD 11
Siemens Material Number: 10446620
Lot Numbers: 42007, 42082, 42483 and 42569
ARTG Number: 178506 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
During recent investigations, Siemens Healthcare Diagnostics has observed that the affected lots have shown reduced on board stability while used on BCS/BCS XP System or Sysmex CA-7000 System as demonstrated by testing appropriate controls e.g. Berichrom Heparin Control 1. The complaints received indicate that there is the potential for invalid runs. Although unlikely, it is possible that an erroneously low heparin value may be reported which may trigger a higher dose of Heparin therapy which could increase the risk of bleeding. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens Healthcare is advising users to discard any remaining inventory of these lots. Affected lots will be replaced by Siemens Healthcare with unaffected stock. Siemens is not recommending lookback of previously reported Berichrom Heparin results since coagulation status changes over time. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |