| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01157-1 |
| Product Name/Description |
Human IgM Kit for use on SPA Plus. An in vitro Diagnostic Medical Device (IVD)
Product Codes: NK012.S & NK012.10S
All lot numbers affected
ARTG Number: 202167 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/L. The antigen excess capacity of this product has been reviewed and has been confirmed as correct. Investigations have suggested that the tested sample contained predominantly monoclonal IgM and the manufacturer believes that this particular type of IgM reacted aberrantly with the antibody and subsequently yielded this spurious result. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies is advising end users of the issue and are updating the instructions for use to reflect the new performance information. |
| Contact Information |
1300 552 003 - In Vitro Technologies Customer Care |