| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01187-1 |
| Product Name/Description |
RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).
RAPIDPoint 400 Measurement Cartridge
Siemens Material Numbers (SMN): 10329756, 10341161
RAPIDPoint 405 Measurement Cartridge
Siemens Material Numbers (SMN): 10844812, 10283222, 10313971, 10310469
Cartridge Serial Numbers: 2610900214 through 2621001325
ARTG Number: 185171 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has confirmed an error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge for certain cartridge serial numbers. The maximum % bias observed due to error ranges from -2.3% at 65mmol/L to +5.9% at 132 mmol/L. At extremely high chloride values (>122 mmol/L), a positive bias of 5% or greater may be observed. There have not been any reports of injury due to this issue.
All the other electrolytes (Na+, K+, Ca++) and blood gas parameters are correctly assigned in these measurement cartridges. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to review the chloride calibrators bias information provided in the recall for product correction letter with their Medical Director.
This action was closed out on the 25/09/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |