| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00098-1 |
| Product Name/Description |
SPAPLuS Analysers. An in vitro diagnostic medical device (IVD)
Catalogue Number: TBSIE610
Manufactured prior to 22 January 2014 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The black foam on the cell fixing plate of older models of SPAPluS analysers can deteriorate over time which can lead to various faults on the analyser. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies is providing their customers with the upgraded Cell Fixing Plate. |
| Contact Information |
1300 932 136 - In Vitro Technologies |