| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00050-1 |
| Product Name/Description |
Dimension Tacrolimus (TACR) Flex Reagent Cartridge, An in vitro diagnostic medical device (IVD)
Catalogue number: DF107 (SMN10444938)
Lot number: FA3316
ARTG 182779 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has confirmed customer complaints of low patient sample recovery with TACR Flex, lot FA3316. Quality Control materials have not exhibited low recovery of the same magnitude. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot FA3316. Laboratory Directors are also being advised to review patient tests to determine if follow-up testing is required. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |