| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00236-1 |
| Product Name/Description |
Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
Catalogue Number: KC130A
Siemens Material Number: 10711579
Lot Number: 5MD004
ARTG Number: 182222 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received complaints of “Calibrator Insert Missing” alerts on the affected Dimension Vista Chemistry 3 Calibrator. Internal investigation has confirmed that the vial barcode label reads KC130 instead of the correct catalogue number KC130A. When this mismatch occurs between the vial barcode label and the Instructions for Use (IFU) label, the “Calibrator Insert Missing” error is triggered and displayed on the Dimension Vista instrument screen. There is no risk of erroneous results when this issue occurs as no results are generated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to use the re-printing options in the Vista system to re-print the affected barcodes. A review of previously generated results is at the discretion of the laboratory director. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |