Events

Recall of DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY

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
    41441
  • Event Risk Class
    III
  • Event Initiated Date
    2015-09-24
  • 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
    Siemens healthcare diagnostics has received customer complaints for the dimension vista magnesium (mg) (k3057 10445158) when using lot 15063ba. the complaints were related to erroneous low results on a small number of reagent wells. data collected from the customer complaints shows that there is the potential for under-recovery on certain wells for quality control (qc) and patient sample results. when this issue occurred the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to -1.6 mg/dl [0.66 mmol/l]. the average under-recovery was -1.0 mg/dl [0.41 mmol/l]. this issue is demonstrating a low frequency of occurrence with an estimated one (1) in every 10000 tests that may be affected. siemens internal investigations were unable to reproduce this issue likely due to the low probability of occurrence. a root cause investigation is ongoing. repeating the sample on a new well of reagent or a new flex cartridge resolves the issue. this issue is likely to be detected by quality control (qc) or calibrators if they are run on the affected wells of reagent.

Device

DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY
  • Model / Serial
    Model Catalog: K3057 (Lot serial: 15063BA)
  • Product Description
    DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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