| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00632-1 |
| Product Name/Description |
BD Stem Cell Control Kit (used with BD FACSCanto flow cytometers). An in vitro diagnostic medical device (IVD)
Catalogue number: 340991
Lot numbers: BC053 & BC063
Expiration dates: 2013-06-02 & 2013-07-02
ARTG number: 197669 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
BD has become aware that some of the affected units are unable to be used for optimisation of BD FACSCanto flow cytometers when performing the BD Stem Cell Enumeration assay. In that case the user will not be able to continue to run the BD Stem Cell Enumeration assay.
As the optimisation setup is manual on the BD FACSCalibur flow cytometer, this potential issue does not arise when using this system. |
| Recall Action |
Recall |
| Recall Action Instructions |
BD is requesting their customers to discard any affected lots of the Stem Cell Control Kit. |
| Contact Information |
1800 656 100 - BD Customer Service |