| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00202-1 |
| Product Name/Description |
LABType SSO Typing Tests and LABType XR/CWD DNA Typing Kits. An in vitro diagnotic medical device (IVD).
Multiple catalogue and batch numbers
ARTG 387517
(Thermo Fisher Scientific Australia Pty Ltd - Human leukocyte antigen A (HLA-A) typing sera IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
The LABType SAPE Buffer in the LABType SSO Typing Tests and LABType XR/CWD DNA Typing kits may generate high background reactivity for multiple bead regions. Multiple bead adjustments may be required to obtain typing information, resulting in a software warning of ‘no solution’ within the HLA Fusion Software. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers may continue to use the product, if the high background is observed with a ‘no solution’ warning message, further confirmatory testing is required.
New vials of buffers can be provided upon request to replace buffers which are part of the affected kits. |
| Contact Information |
1300 735 292 - Customer Care Team |