| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00523-1 |
| Product Name/Description |
ADVIA Chemistry Total Protein_2 reagent (Urine) (UPRO_2). An in vitro diagnostic medical device (IVD).
Lot number: 149411 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Due to the formation of a precipitate in affected lots of the ADVIA Chemistry UPRO_2 reagent indicator dye, an increase in failed calibrations and Quality Control (QC) failures has been observed. These shifts will lead to Quality Control failures resulting in no patient result being reported with the affected kits. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to discontinue use and discard all affected lots. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |