Events

Recall of LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry 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-00972-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00972-1
  • 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
    Internal testing has confirmed customer complaints regarding an upward shift in qc and patient results following calibration with loci cardiac troponin i calibrator lot 3dd007. based on initial internal investigation, siemens estimates that approximately 40% of the calibrator lot is affected. internal testing on patient samples demonstrated an average upward shift of 24% range when compared to an unaffected lot.
  • Action
    Siemens is requesting their customers to immediately discontinue use and discard any remaining inventory from the affected lot. Siemens is recommending to discuss the issues and requirement for retesting with the medical director. The recommendations regarding the need to review previous QC and patient results is limited to samples tested within the past 24 hours.

Device

LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)
  • Model / Serial
    LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)Catalogue Number: RC621Siemens Material Number: 10464336Lot Number: 3DD007ARTG Number: 1822774An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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