| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00233-1 |
| Product Name/Description |
D-dimer Test kit for AQT90 Flex (An in vitro diagnostic medical device (IVD) used as an aid in the diagnosis of venous thromboembolism)
Item Number: 942-915
Batch Number: 942-91508119 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has become aware that during the production process of the D-dimer test kits, a chemical reagent has been missed in a small number of test cups. |
| Recall Action |
Recall |
| Recall Action Instructions |
Radiometer is requesting their customers to inspect their stock and remove and discard any affected lots of D-dimer test kit. |
| Contact Information |
1800 247 254 - Radiometer Pacific |