| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01012-1 |
| Product Name/Description |
Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)
Product Code: S100A1 (EP184)
Affected products:
Cell Marque S100A1 rabbit EP184 0.1 concentrate
Catalogue Number: 408R-14
Cell Marque S100A1 rabbit EP184 1 concentrate
Catalogue Number: 408R-16
Lot numbers: 1335409A to1335409F
ARTG Number: 239099 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Cell Marque has become aware certain lots of the Rabbit Monoclonal Antibody exhibit an unacceptable Immunohistochemistry (IHC ) test result. An investigation was undertaken which showed that lots 1335409A to 1335409F may exhibit a false negative result.
False negative results are readily detected when appropriate tissue controls are used during testing. The manufacturer recommends the use of proper controls when performing IHC staining to detect this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abacus ALS is advising users to destroy any remaining kits of the affected lots. Affected product will be replaced with unaffected kits or credit issued. This action has been closed-out on 02/03/2017. |
| Contact Information |
1800 222 287 - Abacus ALS |