| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01065-1 |
| Product Name/Description |
Autostainer Link 48, AS480
Software version: Dako Link software 4.0.3 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Dako has found a software defect in the calibration routine of DakoLink 4.0. The defect may cause the Autostainer control software to use old calibration settings. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Dako implemented a software update to correct the issue. This action has been closed -out on 28/01/2016
This action was undertaken prior to consultation with the Therapeutic Goods Administration. |
| Contact Information |
02 9922 0700 - Dako Australia |