| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00977-1 |
| Product Name/Description |
RAPIDPoint 500 and 500e Systems Measurement Cartridges (with lactate). An in vitro diagnostic medical device (IVD)
Material numbers: 10491447, 10491448, 10491449
Unique Device Identifiers (UDI): 00630414589756, 00630414589763, 00630414589770
ARTG 176642
(Siemens Healthcare Pty Ltd - Clinical chemistry substrate IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified that has the potential to affect the Sodium (Na+) sensor, as well as cause a Question Result error flag for multiple electrolytes on patient samples and quality control.
When the Na+ sensor is affected, Na+ slope calibration errors (D3) will be seen in the Recall events log during cartridge initialisation, resulting in low Na+ values. The maximum sodium bias on internal testing and reported by customers comparing results to other direct method analysers was <10 mM.
To date, the impact to Na+ results has been observed in less than 1% of the RAPIDPoint 500 Systems Measurement Cartridges (with lactate).
The Question Result “-----?” error flag has been observed on electrolytes. This may occur at any time over the life of the cartridge. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to follow the work around instructions outlined in the customer letter (supplied by the sponsor to affected customers only) for:
- Na measurements depending on if the customer wants to continue reporting Na on a measurement cartridge with lactate or to turn off Na if you do not need to report this analyte.
- The repeated Question Result “-----?” error flag.
Customers are to review the letter with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
Customers may request a no-charge replacement or receive a credit from your local Siemens Healthineers representative if the issues are experinced. |
| Contact Information |
1800 310 300 - Siemens Customer Care Center |