| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01238-1 |
| Product Name/Description |
IMMULITE 2000 and IMMULITE 2000 XPi
Catalogue number: SMN 10381188
Lot number: 314-323
ARTG number: 179720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
In December 2013, Siemens Healthcare Diagnostics issued Urgent Recall for Product Correction (TGA Ref. RC-2014-RN-00002-1) for IMMULITE 2000/IMMULITE 2000 XPi Androstenedione due to an observed over-recovery.
During efforts to restore performance of the Androstenedione assay it was confirmed that the issue noted in December 2013 was not limited to samples >5.5 ng/mL (>19.2 nmol/L). Please refer to Figures 1 and 2 for more information. The root cause of the over-recovery is related to the variability of a critical raw material. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to discard the affected lot of IMMULITE 2000/IMMULITE 2000 XPi Androstenedione.
A laboratory look back is recommended for any existing androstenedione sample(s) with values generated using the affected reagent lots during the period of time within sample stability labelling, and retesting using an alternate method. This action has been closed-out on 16/05/2017. |
| Contact Information |
1800 310 30 - Siemens Technical Support Center |