| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01158-1 |
| Product Name/Description |
ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)
ADVIA 1650
Software versions: V3.52, V4.01
ADVIA 1800
Software version: V2.01
ADVIA 2400
Software version: V4.01
Siemens Reference Number: CHSW 13-03
ARTG Number: 174383 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
When the system switches from the primary reagent pack to the back-up reagent pack, the software may result in the Auto-Calibration or QC to utilise the incorrect values for the Blank and Standard. The systems should not pass calibration and QC, however, the software version affected may allow the system to pass calibration and QC. This may result in a shift in patient results which can be observed through patient trending.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software upgrade will be implemented for ADVIA systems 1800 and 2400 as a permanent fix. As the ADVIA 1650 is planned to be made obsolete effective March 2014 the software update has not been designed for this device. Siemens is providing users with work around instructions to follow as an interim measure. A review of previously generated results is at the discretion of the laboratory director. Thia action has been closed on 28/01/2016 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |