| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00061-1 |
| Product Name/Description |
VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).
Product codes 6800100 and 1H5419
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is the potential for VITROS Vapor Adsorption Cartridges sales unit cartons to incorrectly contain a Particulate Cartridge (part number J19612) |
| Recall Action |
Recall |
| Recall Action Instructions |
Ortho Clinical Diagnostics (OCD) is requesting end users to ensure that a VITROS Vapour Adsorption Cartridge is installed. If a Particulate Cartrtigde is installed it must be replaced immediately with the correct cartridge and reported to OCD Customer Technical Services. Results generated while a Particulate Cartridge was installed must be reviewed. Any concerns with previously reported patient results should be discussed with the laboratory director to determine the appropriate course of action. |
| Contact Information |
1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Services |