| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01303-1 |
| Product Name/Description |
MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
ARTG Number: 288607 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostic Solutions has been advised that as a result of a complaint investigation, it has been determined that MIA FORA NGS Software is impacted by an error in the v3.27.0 Reference Database Update.
Customers testing all 11 HLA genes, 9 HLA genes and 6 HLA genes with the MIA FORA NGS FLEX HLA kits are impacted. Reference sequences specific to HLA-DRB6 and other non-target reference sequences were inadvertently omitted from the v3.27.0 reference database and as a result, this may impact the accuracy of the automatic calls and the need to manually review results. This is most frequently observed with HLA-DPB1 results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Diagnostic Solutions will be in contact with users when a software update is available to include the revised reference database. In the interim, users may utilise either of the following options:
1. Continue use of the v3.27.0 reference database and manually inspect all DPB1 results pending availability of the corrected database; or
2. Revert to v3.24.0. Guidance on how to do this may be provided upon request by Immucor.
Note: after reverting to v3.24.0 users must reanalyse projects previously analysed with the v3.27.0 reference database using the v3.24.0 reference database.
This action has been closed out on the 12/09/2018 |
| Contact Information |
1300 788 003 - Diagnostic Solutions |