| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00719-1 |
| Product Name/Description |
Erytra Eflexis Analyser. An in vitro diagnostic medical device (IVD).
Product Code: 210600
All units with software versions from 1.2.0 to 3.1.0
ARTG 206809
(Grifols Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
Under the following specific conditions, the potential exists for the crossmatch results to be assigned to the incorrect recipient:
1. A crossmatch test has been previously executed for a recipient and at least one donor
2. The "Duplicate the Recipient-Donor Profile Assignments" button was used to repopulate the crossmatch programming window and change the recipient information
3. The crossmatch test results for the previous recipient were in “Pending Validation,” “Validated,” or “Exported” status at the time the crossmatch tests were ordered for the new recipient.
When these specific conditions are met, the crossmatch test ordered for the latest recipient-donor(s) pairing will not be queued. Instead, the results from that first recipient-donor will be removed and assigned to the latest recipient-donor(s) pairing.
If the crossmatch results of the first recipient are exported and the first recipient is no longer available on the instrument, the error does not occur. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Grifols Australia will contact customers to organise a time to implement the software update (version 3.2.0).
In the interim, Diagnostic Grifols recommends customers do not use the 'Duplicate the Recipient-Donor profile assignment' feature' when running Erytra Eflexis, if version 3.2.0 is not installed. |
| Contact Information |
03 9535 9333 - Grifols Australia |