| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00991-1 |
| Product Name/Description |
Human IgG4 Kit Immage Kit
Product code: LK009.IM
ARTG Number: 202167 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
As a result of customer complaints, the manufacturer (The Binding Site) identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies is advising that care must be taken when interpreting results from patients suspected of suffering from IgG4-RSD and recommend that for any patient where the IgG4 concentration does not concur with their clinical history or other test results, the sample should be re-assayed at different dilutions to identify if any antigen excess is occurring. In addition, the IgG4 result should be equated to the total IgG result and any significant discrepancies investigated. The instructions for use have been updated to include these recommendations. This action has been closed-out on 03/02/2017. |
| Contact Information |
1300 552 003 - In Vitro Technologies Customer Care |