Events

Recall of CLINITEK STATUS SYSTEM - URINE CHEMISTRY ANALYZER

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
    84662
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-29
  • 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 is conducting a field action for damaged power supply adaptors that are used in the clinitek status clinitek status+ and clinitek status connect systems which can result in an increased potential for electric shock to the user. this also includes orderable spare parts. siemens is providing information regarding this issue in an urgent field safety notice issued to customers.

Device

CLINITEK STATUS SYSTEM - URINE CHEMISTRY ANALYZER
  • Model / Serial
    Model Catalog: 10376324 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    CLINITEK STATUS SYSTEM-URINE CHEMISTRY ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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