Events

Recall of HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)

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-2013-RN-00315-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00315-1
  • 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
    Issue 1 - siemens healthcare diagnostics have confirmed a positive bias for values below 6%, there is a positive bias of 0.3% with an upper 95% confidence interval of 0.7%.Issue 2 - siemens healthcare diagnostics have confirmed a higher frequency of "above assay range" flags. there is a higher frequency of flags is related to higher recoveries of sample haemoglobin (hb) values (hb >25g/dl or >15.5mmol/l). the hb value is used to calculate the final output hba1c ratio (% hba1c [mmol/mol] result. results are suppressed (not reported) with the "above assay range" flag.
  • Action
    Customers should immediately discard any remaining inventory of the affected lots of Dimension Vista® HbA1c (K3105A). Siemens will replace any unused inventory of the affected lots at no charge. Siemens is recommending customers to discuss the issues with their Medical Director to determine if additional follow up is appropriate for patient tests conducted with the lots affected.

Device

HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vis...
  • Model / Serial
    HbA1c Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)Catalogue Number: K3105ASiemens Material Number (SMN): 10470481Lot numbers: 12072AA, 12086AA, 12107AA, 12128AA, 12150AA, 12191AA, 12212AA, 12226AA, 12248AA, 12261AA, 12282AA, 12303AAARTG: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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