| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00403-1 |
| Product Name/Description |
MIA FORA NGS HLA Server and Software versions 3.0 and 3.1. An in vitro diagnostic medical device (IVD)
MIA FORA NGS HLA Server, Linux SR-790-00017 or Windows SR-790-00020
MIA FORA NGS Software, Linux SR-850-00043, Windows SR-850-00062 or Registry SR-790-00068
ARTG Number: 288607
(Abacus dx Pty Ltd - Interpretive software IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
The following issues have been identified with MIA FORA NGS HLA Server and Software versions 3.0 and 3.1:
1. An anomaly in the MIA FORA NGS software involving the Mismatch in Exon (MME) column of the Allele Candidate table for DRB1,3,4,5 and DQB1;
2. Class I HLA-A primers do not cover the complete 5' and 3' untranslated regions (UTR) as described in the IMGT database;
3. For Class II, the reverse primers for DPB1 overlap a few bases on exon 4; the reverse primer for DPA1 overlaps the last few bases of the 3' end of exon 4; Exon 6 of DQB1 is not included in the amplified product; and
4. The lack of polymorphisms in a region of certain allele combinations of HLA Class I genes may make it challenging to determine the correct phasing for heterozygous samples. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abacus is advising customers that the issues will be corrected in the next revision of the MIA FORA NGS FLEX Software which will include a revised Package Insert to clarify existing or add additional assay limitations. It expected that this software will be released in August 2018.
Until the next revision is available, users should refer to the Appendix provided with the Customer Letter to manually review results.
This action has been closed out on 12/11/2019 |
| Contact Information |
1800 222 287 - Abacus |