| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00212-1 |
| Product Name/Description |
Indiko and Indiko Plus Chemistry Analysers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations have revealed that cuvettes intermittently may be used twice, and as a consequence there is the potential for erroneous results to be generated without the operator being aware that this has occurred. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Thermofisher is advising all end users to immediately stop using any analyser with software versions prior to 5.1.1. Thermo Fisher will provide their customers with a mandatory update to software version 5.1.1. Technical Support will be contacting customers as a matter of urgency to schedule the update. |
| Contact Information |
03 9757 4300 - Thermo Fisher Scientific Australia |