| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00601-1 |
| Product Name/Description |
RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)
Part numbers: 10844813, 10491447, 10491448 & 10491449
Serial Numbers: 2334500011 to 2412705915
ARTG number: 176642 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received several reports from customers of one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) reporting a “-----?” error code when AQC, QC, or CVM is run on the RAPIDPoint 500 blood gas analyzer. When exhibited, the issue is usually seen during Level 1 QC /AQC, Level 1 CVM, and sometimes Level 2 CVM testing. This issue has also been observed on a small number of patient samples. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised that the following steps can be taken to mitigate the issue:
- Install a RAPIDPoint 500 Measurement Cartridge
or
- Install a 405 Measurement Cartridge. Customers will need to arrange to get the lactate results from other instruments in their central laboratory since the Lactate parameter is not available on the RAPIDPoint 405 cartridge
or
- Use an alternative system to obtain the electrolyte values.
Since this issue is not related to the AQC cartridge, installing a new AQC cartridge will not solve the problem. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |