| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01357-1 |
| Product Name/Description |
NCL-L-CD15. An in vitro diagnostic medical device (IVD).
(NovocastraT Liquid Mouse Monoclonal Antibody)
Lot Number: 6024628 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Leica Biosystems recently became aware that the product listed above does not function as intended up to the expiry date on the product labelling. There is a link between the age of the product and staining intensity. No customer complaints relating to this issue have been received.
There is the potential risk of a patient being diagnosed with incorrect tumor based on a false negative CD15 staining result. Delay in diagnosis/ misdiagnosis of a patient with Hodgkin’s Disease. Positive control tissue would show weaker than expected or negative staining. An unexpected result would be highlighted by the use of appropriate controls. Additionally, if a pathologist did not follow standard medical practice there could be a possibility that an incorrect or delayed diagnosis could result and appropriate treatment for the patient could be delayed. This could possibly result in improper staging of the patient’s disease or resulting in the patient’s death.
|
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to discard any remaining product from the affected lot and contact their Leica representative immediately if a replacement is required. |
| Contact Information |
03 9211 7535 - Leica Biosystems Melbourne |