Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00416-1 |
Product Name/Description |
RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Numbers:10321846, 10491394, 10339910
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Numbers: 10321852, 10470366, 10491395, 10335524
ARTG number: 175890 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
15/05/2015 |
Responsible Entity |
|
Reason/Issue |
The analyzers will potentially not indicate the error codes below:
Error Code: D50 Glucose Sensor Error Problem: The system detects an open connection in the Glucose Biosensor
Error Code: D51 Lactate Sensor Error Problem: The system detects an open connection in the Lactate Biosensor.
If the error codes were functioning properly, glucose or lactate results would be suppressed in the presence of their respective code. While a disconnected glucose sensor could result in falsely elevated or depressed glucose values, the risk is limited to a falsely elevated glucose result that could potentially lead to a missed or delayed diagnosis of hypoglycemia requiring intervention. While a disconnected Lactate sensor could result in falsely elevated or depressed lactate values, the primary risk is limited to a falsely depressed result that could potentially lead to a missed/delayed diagnosisand/or an inaccurate evaluation of the severity of sepsis, ischaemic and hypoxic conditions. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
A look-back of previous results is at the discretion of the laboratory. A new software version for the RAPIDLab 1260 and RAPIDLab 1265 analyzers is being developed to address this issue, and will be provided by Siemens as soon as it is available. In the interim, users are advised to ensure that the Glucose and Lactate sensor contacts are aligned and completely seated with the contacts on the analyzer and analyze a minimum of 2 levels of quality control material after installing the sensors, as indicated in the RAPIDLab 1200 Operator’s Guide.
This action has been closed out on 7/09/2018. |
Contact Information |
1800 310 300 - Siemens Technical Support Centre |