| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00355-1 |
| Product Name/Description |
Liquichek ToRCH Plus IgM Control - Positive (An in vitro diagnostic medical device (IVD))
Catalogue Numbers: 229 and 229PX
Lot Number: 18972 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
This product contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Rad is asking users to destroy the affected stock using appropriate disposal methods. |
| Contact Information |
1800 224 354 - Bio-Rad Customer Service |