| TGA Action ID |
RC-2025-RN-00792-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Erytra analyser with software versions from 4.5.0. An in vitro diagnostic medical device (IVD)
Product Code: 210400
Serial Numbers: 059-0000812, 059-0000982, 059-0001472, 059-0001473, 059-0001597, 059-0001448, 059-0001434 |
| ARTG Number |
206809 |
| Unique Device Identifier (UDI) |
08436583730935 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Incorrect results can be assigned for an autocancelled and rescheduled test.
A correct result is obtained for the rescheduled test while no results are obtained for the auto-cancelled one.
The interpretation of the rescheduled test is shown in the results detail screen and traceability report. However, the system shows a wrong result interpretation in the results screen and this result is sent to the LIS.
The incident may occur due to a rare concurrency problem in the database management.
Three conditions must be met to trigger the incident:
1)A test is automatically cancelled and rescheduled
2)This test is rescheduled while its status is already RUNNING
3)The software is not able to successfully discard the cancelled test.
Due to this error, the test remains internally linked to two different instances of the technique, the cancelled one, and the one that is created upon rescheduling. The microtube results from the cancelled execution have no information but the software assigns a default interpretation result. The information contained in the executed instance is correct. However, the interpretation result shown in the results screen for this technique is from the cancelled technique instance.
An incorrect assignment of results could lead to a serious incident if a transfusion is performed based on the incorrect results.
Grifols had not received any reports of this problem to date. |
| Instructions for Customers/Users |
- For software version 4.5.0, install patch v4.5.1 on Erytra analyzer, which is already available and can be remotely installed, or to install software version v4.6.1, which will be available for installation in the next weeks.
- For software version 4.6.0, install software version 4.6.1 on Erytra analyzer, which will be available for installation in the next weeks.
- Interim Measures: Until the software update is completed, the auto-export configuration must be deactivated. All results should be manually reviewed in the Test Details tab within the Results menu to verify that there are no duplicate executions of the technique.
If a duplicate execution is found, the corresponding sample profile should be rejected and the execution repeated.
- A review of the customer analyzer database will be conducted by a Technical Service Representative to detect any potentially affected result since the installation of version 4.5.0.
This action has been closed out on 18/12/2025 |
| Action Commencement Date |
16/09/2025 |
| Responsible Entity |
|
| Contact Information |
03 9535 9333 - Grifols Australia |