Events

Recall of DIMENSION VISTA SYSTEM - MASS CREATINE KINASE MB ISOENZYME (MMB)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    51583
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The biotin concentration in the non-interfering table for dimension ft4l and tshl and dimension vista tsh is incorrect and the biotin concentration is being revised. in addition dimension vista ctni and mmb and dimension siro do not indicate biotin interference in the non-interfering table of the ifu. the ifu will be updated with the established claim for biotin.

Device

DIMENSION VISTA SYSTEM - MASS CREATINE KINASE MB ISOENZYME (MMB)
  • Model / Serial
    Model Catalog: K6420 (Lot serial: ALL); Model Catalog: DF306 (Lot serial: ALL); Model Catalog: K6421 (Lot serial: ALL); Model Catalog: RF612 (Lot serial: ALL); Model Catalog: RF610 (Lot serial: ALL); Model Catalog: K6412 (Lot serial: ALL)
  • Product Description
    DIMENSION VISTA SYSTEM-MASS CREATINE KINASE MB ISOENZYME (MMB);DIMENSION EXL SYSTEM-SIROLIMUS (SIRO) ASSAY;DIMENSION VISTA SYSTEM-CARDIAC TROPONIN I (CTNI);DIMENSION EXL SYSTEM-THYROID STIMULATING HORMONE (TSHL) ASSAY;DIMENSION EXL SYSTEM-FREE THYROXINE (
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC