| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00392-1 |
| Product Name/Description |
Dimension TACR (Tacrolimus) Flex Reagent Cartridge (DF107), An in vitro diagnostic medical device (IVD)
Catalogue number: 10444938
Lot number: 2ED072 and 2KD084
ARTG: 182779 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Siemens previously communicated an issue with low bias on patient results for Dimension Tacrolimus Flex reagent cartridge lot FA3316 (Urgent Medical Device Recall DC 13-02A and TGA ref RC-2013-RN-00050-1). Siemens will be implementing linking of specific Dimension TACR calibrator lots with specific Dimension TACR Flex lots to ensure accurate recovery and continued traceability of patient results to the LCMS reference method. Due to the requirement for linked calibrators, lots 2ED072 and 2KD084 can no longer be used. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot 2ED072 and 2KD084. To ensure the correct linkage between calibrator and reagent lots, customers are requested to contact their Siemens customer service to order lot linked combinations. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |