Events

Recall of Siemens Dimension Vista Hemoglobin A1c (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
    17429
  • Event Initiated Date
    2014-09-25
  • 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
    Siemens has confirmed that certain lots of the dimension vista® hba1c flex® reagent cartridge exhibit a positive bias averaging 0.4% [4.4 mmol/mol] hemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp). qc samples may exhibit a similar bias.
  • Action
    Product to be destroyed

Device

Siemens Dimension Vista Hemoglobin A1c (HbA1c) Flex Reagent Cartridge
  • Model / Serial
    Model: Catalogue Number: K3105A, Affected: Lots: 13294BA, 13308BA, 13329AA, 13350AA, 14006AA, 14041BA, 14069BB, 14083BA
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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