Events

Recall of Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical device (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-2014-RN-01084-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01084-1
  • 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 healthcare diagnostics has determined that dimension vista mass ckmb isoenzyme calibrator (mmb cal) shows drift during routine stability monitoring that exceeds siemens acceptance criteria for drift over the shelf life of this product. siemens has observed drift from 3% to 12% at mmb concentrations across the assay range. depending on quality control limits, this drift may not have been detected. due to the drift, siemens is revising the expiration date of this product. the manufacturer has confirmed routine stability monitoring data for mmb cal only supports six months. product is labelled for 12 months.
  • Action
    Siemens Healthcare Diagnostics is requesting the customers to discard any remaining inventory of MMB CAL lots and to recalibrate with lot 4FD073 on next calibration. Review of previous testing is at discretion of the laboratory. This action has been closed-out on 04/04/2017.

Device

Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical ...
  • Model / Serial
    Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10445195Test Code: 0317Catalogue Number: KC672Lot Numbers: 3JD045,4BD064, 4CD012, 4DD065ARTG Number 182776
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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