| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00661-1 |
| Product Name/Description |
Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)
Product Code: ENZ II CAL
Catalogue Number: DC143
Siemens Material Number (SMN): 10476170
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 the affected Dimension Enzyme II 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 results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens has reassigned the bottle values of all Enzyme II 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.
This action has been closed on the 14/09/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |