| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01041-1 |
| Product Name/Description |
OriGen Syringe DMSO (Used for Research Use Only)
Multiple part numbers and lot numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
Pure DMSO is reacting with syringe polymers and degrading during storage and DMSo begins to show a light yellow color. Purity has dropped from 99.9% to 99.6% after six months in storage.
This recall action was not notified to the TGA before it was initiated by Diagnostic Solutions Pty Ltd |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is asking users to quarantine and remove affected product and is supplying an alternative syringe until a replacement is available. |
| Contact Information |
03 8470 5400 - Diagnostic Solutions |