Events

Recall of Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid Stimulating Hormone

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
    21294
  • Event Initiated Date
    2017-10-24
  • 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
    Update 23 october 2017 to march 2017 urgent recall for product correction regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension® and dimension vista® assays. ongoing investigation has identified the following new information regarding biotin interference:, 1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the following assays: dimension tshl, dimension ft4l and dimension vista tsh. concentrations of biotin above the concentration listed in table 2 in the revised biotin non-interference column can potentially result in interference >10%., 2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin above the concentration in the revised biotin non-interference column can potentially result in interference >10%.
  • Action
    Manufacturer to issue advice regarding use

Device

Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid St...
  • Model / Serial
    Model: Thyroid Stimulating Hormone (TSHL), LOCI Free Thyroxine (FT4L), Thyroid Stimulating Hormone (TSH), Cardiac Troponin I (CTNI), Mass creatine kinase MB isoenzyme (MMB), Sirolimus (SIRO), All lots (including all future lots until Instructions For Use update), Affected: DM Troponin I (TNI), DV Digoxin (DIGXN), DV Estradiol (E2), DV Ferritin (FERR), DV Prolactin (PRL), DV Thyroid Stimulating Hormone (TSH) All lots including all future lots until instructions of use is updated
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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