| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01133-1 |
| Product Name/Description |
IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi - Calcitonin Control Module
Catalogue Number: SMN 10385383
Lot Number: 0019
ARTG Number: 179720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified a typographical error in the IMMULITE Calcitonin Control Module Instructions For Use (IFU). The published expiration date in the IFU is 2017-10. The correct expiration date is 2017-01. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are requested to discard the affected product IFU and provided instructions to check the system to ensure that the correct expiry date is entered in the system. This action has been closed-out on 18/03/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |