| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00750-1 |
| Product Name/Description |
Dimension Vista RF Flex Reagent Cartridge (an in vitro diagnostic medical device (IVD)
Catalogue Number: K7068
Lot Number: 12283MA
ARTG Number: 178155 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors (E143: Abnormal Assay) with the Dimension Vista RF Flex reagent cartridge lot 12283MA. The errors can occur on calibration, QC and/or patient sample. Any result produced with the Abnormal Assay error is deemed non-reportable as stated in the Dimension Vista Operator's Guide (section 5-49). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens Healthcare is advising users to discontinue use and discard remaining inventory. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |