| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01198-1 |
| Product Name/Description |
Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)
Model number: CS10330
ARTG: 181957 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Based on an investigation it has been concluded that the expected lifetime of the CoverStainer racks does not meet the set requirements. The consequence can be that slides are falling out of the rack during the staining process. Slides falling out of the rack during the staining process would require a new slide preparation and staining process to be initiated. In the rare event, the patient may need to be called in for a new sample to be taken.
This recall action was not notified to the TGA before it was initiated by Dako Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Dako Australia Pty Ltd has advised their customer to discontinue use and return the Coverstainer Slide Racks for replacement. |
| Contact Information |
1800 653 103 - Dako Australia |