| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00389-1 |
| Product Name/Description |
ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
Catalogue Numbers: 02419937 (116734) and 03896216 (116735) respectively
Siemens Material Numbers (SMN): 10333349 and 10334837 respectively
Lots ending in 2577 and all future lots
Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP
ARTG Number: 175636 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
There is confirmation that the ADVIA Centaur BR (CA 27.29) assay does not dilute linearly when used with Multi-Diluent 1 kit. When diluted, some samples over-recover the expected neat value by greater than 120%. Dilution of samples with results greater than the analytical measuring range for the ADVIA Centaur BR (CA 27.29) assay may be important for serial measurements during treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is requesting users to discontinue dilution of samples using the ADVIA Centaur systems BR (CA 27.29) with Multi-Diluent 1 kit lots ending in 2577 and future lots of Multi-Diluent 1 until further notice. Users are advised to contact their local Siemens Customer Care Centre or their local Siemens technical support representative if they receive any complaints of illness or adverse events associated with the affected products.
This action has been closed out on 30/01/2020 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |