| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00352-1 |
| Product Name/Description |
TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD)
TCAutomation System
Product Code: 6844300
Thermo Scientific Recapper Module (230V)
Product Code: 952036 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate. This may result in contamination of patient samples and affect patient diagnosis or treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical is advising users to check the affected systems to identify if the electrical cable has migrated out of position. A Service Representative will secure the cable in place above the support vibration feeder plate. This action has been closed-out on 09/05/2017. |
| Contact Information |
1800 032 359 - Ortho Technical Solutions Centre |