Recall of Siemens Dimension Vista Haemaglobin HbA1c Flex Reagent Cartridge

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
    17210
  • Event Initiated Date
    2017-11-02
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    This is a follow up letter to recall action issued in august 2014 to advise that the small sample container (ssc) can be used with the dimension vista® hemoglobin a1c (hba1c) assay with software version 3.6.2 or higher.
  • Action
    Manufacturer to issue advice regarding use

Device

  • Model / Serial
    Model: K3105A, Affected: Lots: 13252AA 13259AA 13273BA 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA 14132BA
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA