Events

Recall of Siemens RAPIDLab 1260/1265 Systems, D50 Glucose Sensor and D51 Lactate Sensor

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Siemens Healthcare Diagnostics Inc.

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
    18490
  • Event Initiated Date
    2015-05-15
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    If the glucose or lactate sensors are not completely seated with the contacts on the instrument, glucose or lactate results could be generated when, instead, the instrument should alert the operator with a d50 glucose sensor error or a d51 lactate sensor error.
  • Action
    Software to be upgraded

Device

Siemens RAPIDLab 1260/1265 Systems, D50 Glucose Sensor and D51 Lactate Sensor
  • Model / Serial
    Model: 10321846, 10491394, 10339910 (RAPIDLab 1260); 10321852, 10470366, 10491395, 10335524 (RAPIDLab 1265), Affected: All systems
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA