| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00662-1 |
| Product Name/Description |
Dimension Vista Enzyme 2 Calibrator (used on the Dimension Vista System). An in vitro diagnostic medical device (IVD)
Product Code: ENZ 2 CAL
Catalogue Number: KC321
Siemens Material Number (SMN): 10475527
Multiple Lot Numbers and Expiry Dates affected
ARTG Number: 181688 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is calibrated with certain Dimension Vista Enzyme 2 Calibrator lots. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. There is no risk to patients however there may be a delay in reporting patient results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has reassigned the bottle values of all Enzyme 2 calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided.
A review of previously generated results due to this issue is at the discretion of the laboratory. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |