| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00855-1 |
| Product Name/Description |
RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD)
RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 tests
Serial Numbers affected: 2517102517 through 2519000012.
Please note: Cartridges within the affected serial number range that have a green dot on the box and/or the cartridge are not affected.
ARTG Number: 176642 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
During the manufacturing process, the Sodium high calibrator value was incorrectly assigned for the RAPIDPoint 500 Measurement Cartridge causing a negative bias on both QC and patient samples.
This issue causes a varying negative bias across the measurement range, with the bias increasing with increasing sodium concentrations. Taking into account the magnitude of the bias near the reference interval, this issue is not expected to cause clinically significant changes to patient treatment decisions for hypernatremia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is notifying laboratories of the error and that the review of previously generated results is at the discretion of the laboratory. Laboratories are given the option to return the affected products. This action has been closed-out on 07/09/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |