Events

Recall of Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (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-2013-RN-00171-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00171-1
  • 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
    Siemens has confirmed complaints of low qc and patient recovery with the dimension vista® loci digoxin (digxn) flex® reagent cartridge when calibrating digxn with either drug 4 cal (kc460) lot 2kd052 or drug 4 cal (kc460a) lot 2kd053. internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/ml.
  • Action
    Customers are requested to immediately discard any remaining stock. Siemens is asking customers to discuss the issues with the laboratory director so that they can determine if additional follow-up is required for patient tests conducted with the affected lots.

Device

Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagno...
  • Model / Serial
    Drug 4 Cal (KC460) & Drug 4 Cal (KC460A) for use with the Dimension Vista System. In vitro diagnostic medical devices (IVD).Vista Drug 4 CalibratorCatalogue number: KC460 Siemens material number: 10472284Lot number: 2KD052 Vista Drug 4 Calibrator Lot (SMN ) Catalogue number: KC460A Siemens material number: 10476171Lot number: 2KD053 ARTG Number: 182220
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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