| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00486-1 |
| Product Name/Description |
EliA GBM Wells. An in vitro diagnostic medical device (IVD)
All lots
ARTG 229585
(Abacus dx Pty Ltd - Clinical chemistry autoimmune IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
In May 2023 Abacus dx issued a Product Defect Alert (RC-2023-RN-00422-1) due to Phadia AB receiving multiple customer complaints about false positive EliA GBM results. Following their investigation Abacus dx is providing further information and customer actions.
It has been confirmed the problem arose from an unspecific reaction to a BSA component in the coating solution used in the EliA GBM Well. Despite this, the test’s diagnostic sensitivity (93.5%) and specificity (100%) remain within acceptable ranges. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abacus dx no longer recommends the need for retesting of samples with a positive test result for EliA GBM Well (>10 EliA U/ml) as suggested previously in RC-2023-RN-00422-1.
Use of the EliA GBM Well can continue as detailed in the current user manual and the DfU. Place the customer letter (which includes the update DfU wording) with the current IFU/DfU.
The EliA GBM DfU will be updated. The following information will be added to the "Limitations" chapter within the EliA GBM DfU: 'When assessing the clinical significance of a positive test result, it should be considered that anti-GBM disease is a very rare condition, which impacts the positive predictive value of the test. Falsely elevated test results can occur due to specific binding of serum antibodies to blocking reagents, such as BSA.' |
| Contact Information |
1800 222 287 - Abacus dx Pty Ltd |