| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00179-1 |
| Product Name/Description |
Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)
Catalogue Number: OWWR15, OWWR17
Siemens Material Number (SMN): 10446672, 10446673
Lot Number: 45029, 45027
ARTG Number: 178559 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that some packages of the Berichrom Antithrombin III kit may contain a different substrate reagent lot as given in the package labelling. Dependent on the instrument used, some instruments with automatic reagent identification may request a new calibration.
The correct substrate reagent lot number is 520294.
This issue has no impact on patient results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens Healthcare is advising users that the affected product will be replaced with unaffected stock. This action has been closed-out on 03/02/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |