| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00704-1 |
| Product Name/Description |
BD Vacutainer CPT Cell Preparation Tube. An in vitro diagnostic medical device (IVD).
Catalogue Number: 362761
Lot Numbers: 4063411 & 4090230
ARTG Number: 177829 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
BD is conducting a recall of the above mentioned blood collection tube due to poor separation resulting in a reduced number of recovered mononuclear cells. Having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection, potential delay of treatment, and in remote cases, could lead to erroneous results. |
| Recall Action |
Recall |
| Recall Action Instructions |
BD is requesting their customers to check their inventory and quarantine product subject to this recall. BD will arrange for the collection and replacement of all affected stock. |
| Contact Information |
02 8875 7045 - Becton Dickinson |