| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01048-1 |
| Product Name/Description |
Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device (IVD)
Catalogue Number: KC330
Siemens Material Number: SMN 10445181
Lot number recalled : 2AD052
Lot numbers whose shelf life will be reduced: 2GD011 and higher
ARTG Number: 181688 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
1/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received customer inquiries regarding correlation slope bias when comparing the Dimension Vista ALP method to the Dimension® ALP method. Siemens' internal investigation has confirmed that the activity of the Dimension VistaALP CAL, KC330, changes as the product ages and contributes to this correlation slope bias as well as accuracy shift. The magnitude of the accuracy shift is the same for QC and patient samples and does not exceed the allowable bias for the Dimension Vista ALP assay. In order to ensure better correlation and accuracy, the shelf life for the Dimension Vista ALP CAL has been decreased from 12 months to 4 months. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is providing work around instructions for users to implement. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |