| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00171-1 |
| Product Name/Description |
Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (IVD).
Vista Drug 4 Calibrator
Catalogue number: KC460
Siemens material number: 10472284
Lot number: 2KD052
Vista Drug 4 Calibrator Lot (SMN )
Catalogue number: KC460A
Siemens material number: 10476171
Lot number: 2KD053
ARTG Number: 182220 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista® LOCI Digoxin (DIGXN) Flex® reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to immediately discard any remaining stock. Siemens is asking customers to discuss the issues with the laboratory director so that they can determine if additional follow-up is required for patient tests conducted with the affected lots. |
| Contact Information |
1800 310 300 - Siemens Technical Support |