| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00633-1 |
| Product Name/Description |
HemosIL AcuStar ADAMTS13 Activity. An in vitro diagnostic medical device (IVD)
Part number: 0009802048
Lot numbers: All
ARTG 191094
(Werfen Australia Pty Ltd - Coagulation factor IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
HemosIL AcuStar ADAMTS13 Activity results were below the medical decision level (< 10% activity), and a comparator assay reported results above the medical decision level and in certain instances patient treatment was initiated based on the ACL AcuStar results.
The increased adoption of new Thrombotic Thrombocytopenic Purpura (TTP) therapies that potentially increase the risk of bleeding, reinforces the need to take ADAMTS13 activity results in conjunction with other clinical and laboratory findings.
In addition, some of these reports include use of HemosIL AcuStar ADAMTS13 Activity with paediatric patients although the assay is currently labelled for use in the adult population. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised:
- Results of the assay should always be interpreted in conjunction with other clinical and laboratory findings.
- The use of the assay to guide patient therapy plan (e.g., plasma exchange, rituximab and caplacizumab) has not been evaluated.
- The assay has not been validated for use in the paediatric population and claims in the IFU are not applicable to this population.
- The assay has not been validated for evaluating TTP relapse or recurrence.
Once the current investigation has been completed, the IFU will be updated. |
| Contact Information |
02 9098 0200 - Kieran Pickles - General Manager, Werfen Australia |