| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00849-3 |
| Product Name/Description |
Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). An in vitro diagnostic medical device (IVD)
Catalogue Number: DF105A
Lot Numbers: GA3169, GA3162, GA3141, GA3134, GA3113 & GA3099
ARTG Number: 181689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has received complaints of inaccurate results after calibration of HB1C (DF105A). Accuracy shifts of up to 27%, both high and low, have been reported on QC and patient samples. The shift observed with QC material is consistent with the direction and magnitude of the shift observed with patient samples. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End user to use updated scaler values for calibration of all affected lots. |
| Contact Information |
1800 310 300 - Siemens Technical Supoprt Centre |