| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00347-1 |
| Product Name/Description |
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD).
Dimension Vista 500 Intelligent Lab System
Siemens Material Number (SMN) 10488224
Dimension Vista 1500 Intelligent Lab System
Siemens Material Number (SMN) 10444802
ARTG number: 174699 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
There has been confirmation that in isolated cases when Enzymatic Creatinine (ECREA) is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result. Whilst it is understood that users routinely run Quality Control (QC) after system maintenance, it is particularly important to run ECREA QC after the Probe Test to identify a potentially elevated ECREA result. (Please note that this information applies only to laboratories processing enzymatic creatinine (ECREA: Enzymatic Creatinine Cat No. K1270A, SMN 10700444) after the implementation of the automated Acid Clean (ACLN) maintenance routine). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is recommending affected users to adhere to the following steps:
1) replace the appropriate reagent probe (only if the ECREA reagent probe has not been replaced since the activation of ACLN)
2) process QC which includes ECREA immediately after routinely scheduled Off Peak Activities including Probe Test; and
3) contact Siemens Customer Care Centre IF, after replacement of reagent probe, users experience elevated ECREA QC results directly after Off Peak Activities which includes the Probe Test or after manually processing the Probe Test.
This action has been closed out on 07/11/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |