| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00019-1 |
| Product Name/Description |
INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)
Catalogue Number: B4170-22
Siemens Material Number (SMN): 10445700
Lot Numbers: 5464024; 5464025; 5464026; 5464027
ARTG Number: 178507 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that INNOVANCE PFA P2Y cartridge lots 5464024, 5464025, 5464026 and 5464027 show falsely extended shelf life.
Internal investigations have shown that INNOVANCE PFA P2Y cartridges used beyond the correct but within the displayed shelf life date showed a maximal deviation of down to -11% which is within the overall performance claims. There is no risk to health. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising users not to use units from the affected lots beyond the correct shelf life dates given in the customer letter. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 310 300: Siemens Technical Support Centre |