| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00150-1 |
| Product Name/Description |
The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)
All serial numbers with ‘C’ suffix
Catalogue number: TBSIE610
ARTG Number: 201723 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
In Vitro Technologies have been notified by the manufacturer that the “Prog Error (overflow) DET Comm” pop-up message has been recently reported on a number of the SPAPLuS analysers with the ‘C’ suffix on the serial number. When the error occurs, analysis will stop and a full shutdown is required to restart testing. In addition to this, it causes results to be lost and the test will be required to be repeated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies are advising users that a build up of static is the cause of the issue. A grounding unit will be installed on all affected units to prevent the error from occurring. |
| Contact Information |
1300 932 136 - In Vitro Technologies |