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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 Becton Dickinson Pty Ltd
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