Events

Recall of RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00416-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00416-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    RAPIDLab 1260/1265 Systems. An in vitro diagnostic medical device (IVD)RAPIDLab 1260 Blood Gas AnalyzerSiemens Material Numbers:10321846, 10491394, 10339910 RAPIDLab 1265 Blood Gas AnalyzerSiemens Material Numbers: 10321852, 10470366, 10491395, 10335524ARTG number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA