| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01219-1 |
| Product Name/Description |
VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. An in vitro diagnostic medical device (IVD)
VITROS 3600 Immunodiagnostic Systems (Product Code 6802783)
VITROS 4600 Chemistry Systems (Product Code 6802445)
VITROS 5600 Integrated Systems (Product Code 6802413)
VITROS 5,1 FS Chemistry Systems (Product Code 6801375, 6801890) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports regarding a potential malfunction in a wire connector used in the VITROS Systems. There have been reports of the smell of melting plastic or smoke originating from the affected systems. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical Diagnostics is correcting the wire connector to prevent the occurance of over heating. |
| Contact Information |
1800 032 359 - Customer Technical Services |