| TGA Action ID |
RC-2025-RN-00389-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Mitra Microsampler Blood Collection Devices. An in vitro diagnostic medical device (IVD)
Product number: VM-102SNLD
Batch numbers: 133977 (with Tip Lot Number 71116A-P5L18-20135 on the Certificate of Conformity)
Expiration date: 31-JAN-2026 |
| ARTG Number |
280007 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class III |
| Reason for the Action |
Three complaints have been received for the Mitra Devices from 2 different finished goods lots, indicating that slow or insignificant blood wicking may prevent optimal collection of the specimen beyond the specified maximum wicking time. The problem has been observed in only a subset of the devices in the two lots.
While this problem may delay laboratory testing for patients using the device for diagnostic purposes, there have been no reports of diagnostics failures using the products.
Update 23/07/2025: Trajan has updated the Instructions for Use (IFU) for the Mitra Device to clarify that multiple undersampling events should be reported immediately. This change addresses the common misconception that undersampling is solely due to poor technique and aims to reduce stress for healthcare providers and patients while enabling timely assessment of potential product defects. |
| Instructions for Customers/Users |
Customers are to be aware that Trajan Scientific Australia:
· Will issue a detailed description of the problem, enabling them to assess if they have been impacted by the observed defect.
· Will provide an equivalent replacement for any problems noted.
· Will gather feedback on their experience to supporting ongoing improvements.
· Has implemented new process to detect this defect before assembly, preventing similar problems in future.
Update 23/07/2025
The update to the IFU is as below:
· The IFU already includes guidance for optimal finger blood sampling, noting that undersampling due to insufficient blood expression should be rare.
· It acknowledges that while experienced users can easily identify failed collections, less experienced users might misinterpret them as technique errors.
· A new warning has been added to the IFU advising users to report multiple undersampling events, enabling timely support and investigation of potential product problems.
This action has been closed out on 11/12/2025. |
| Action Commencement Date |
14/04/2025 |
| Responsible Entity |
|
| Contact Information |
AWhalen@trajanscimed.com - Anne Marie Whalen, PhD |