| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00424-1 |
| Product Name/Description |
LymphoTrack Dx IGHV Leader Somatic Hypermutation Assay Panel – MiSeq. An in vitro diagnostic medical device (IVD)
Catalogue number: 91210069
Kit lot number: N0000813
Master Mix part number: 21210319CE
Master Mix lot number: N0000437
ARTG 255352
(Abacus dx Pty Ltd - Acquired genetic alteration IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
The LymphoTrack Dx IGHV Leader Somatic Hypermutation Assays contain multiple primers in the VH3 region of the IGH locus. However, the IGH Leader MiSeq Index 08 Master Mix is missing one VH3 primer which significantly contributes to the identification of clonal VH3 sequences. Similarly, the impacted IGH Leader MiSeq Index 12 Master Mix is missing one primer located in the VH5 region of the IGH locus which would likely be required for the identification of a clonal VH5 sequence. A false result from a non-detected VH3 and/or VH5 rearrangement could result in an adverse event if the false result impacted patient treatment decisions. |
| Recall Action |
Recall |
| Recall Action Instructions |
- Discontinue use and destroy any remaining defective components.
- Provide confirmation that all remaining defective products were destroyed along with any request for replacement product(s)
- Inform the manufacturer of any known false negative results.
- Retesting residual clinical sample against a different Master Mix may be performed, if necessary. |
| Contact Information |
1800 222 287 - Abacus dx Pty Ltd |