| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00369-1 |
| Product Name/Description |
IMMULITE 2000 IMMULITE 2000 XPi Immunoassay System. An in vitro diagnostic medical device (IVD)
Reagent Carousel Temperature Sensor Printed Circuit Board (PCB) Assembly
ARTG number: 174399 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified that some systems may have been manufactured with a defective reagent carousel temperature sensor PCB or a defective PCB assembly.
The affected temperature sensor boards may cause icing on the reagent carousel casting. If there is icing within the reagent carousel, there is a potential for the reagent carousel to encounter a mechanical jam which will stop the system from processing samples and will generate errors.
Siemens has determined that the reagent contents do not freeze when the incorrectly assembled PCB assembly is installed in the reagent carousel assembly. Testing shows that the reagent liquid temperature may fall below 4 °C but not to the point when freezing or slush was observed. The reagents are not compromised; therefore, assay performance is not affected.
There is not likely to be any risk to health. The system will stop processing samples if a mechanical jam occurs. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens will inspect all systems for the defect on the next service visit. In the interim users are requested to contact Siemens Technical Support should an Error [465] or [302] occur. This action has been closed-out on 03/03/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |