| TGA Action ID |
RC-2025-RN-00052-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
HemosIL AcuStar ADAMTS13. An in vitro diagnostic medical device (IVD)
Lot Number: All lot number
Product Code: 0009802048
Expiry Date: 01.07.2025 |
| ARTG Number |
191094 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Wefen Australia Pty Ltd issued a notice which serves as clarification and closure to the previously sent Urgent Product Defect Correction (Dated August 2024) regarding HemosIL AcuStar ADAMTS13 Activity.The original notice was issued due to reports of serious injury in patients where HemosIL AcuStar ADAMTS13 Activity results were below the medical decision level (< 10% activity), while a comparator assay reported results above the medical decision level. The notice was intended to reinforce the assay’s labelled intended use and performance claims.
The assessment has concluded that HemosIL AcuStar ADAMTS13 Activity remains safe for its labelled intended use and continues to be a valuable tool as an aid in the diagnosis Thrombotic Thrombocytopenic Purpura (TTP), when used as labelled. To help prevent misinterpretation of discrepant results, it is recommended that facilities follow a robust test algorithm pathway for treating TTP, incorporating clinical information and laboratory findings. |
| Instructions for Customers/Users |
Customers are to:
· Use HemosIL AcuStar ADAMTS13 Activity according to its labeled intended use.
· Evaluate patient results based on the clarifications and best practices described in the updated IFU.
· Assess whether additional testing is necessary before taking clinical action for results that are inconsistent with other clinical or laboratory findings.
· Be aware that while there is a potential for misinterpretation of discrepant results between the HemosIL and ELISA based assays, removing the AcuStar ADAMTS13 Activity would cause delays in diagnosing serious conditions such as TTP, leading to delayed treatments and increased risk of morbidity and mortality.
· The root cause investigation identified that a reformulation of the assay buffer could improve the alignment of the HemosIL AcuStar ADAMTS13 Activity assay’s performance with other methods and reduce discrepant results. This will be undertaken as part of a longer-term project.
This action has been finalised on 11/9/2025. |
| Action Commencement Date |
24/04/2025 |
| Responsible Entity |
|
| Contact Information |
02 9098 0202 - Azadeh Zargari |