RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00416-1

Class II

2015-05-15

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00416-1

The analyzers will potentially not indicate the error codes below: error code: d50 glucose sensor errorproblem: the system detects an open connection in the glucose biosensorerror code: d51 lactate sensor errorproblem: 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.

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.