Events

Recall of CLINITEK NOVUS AUTOMATED URINE CHEMISTRY ANALYZER (WITH RACK HANDLER)

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
    31271
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-12
  • 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 identified a potential pinch hazard in the interior of clinitek novus analyzer. the potential pinch hazard is in the area of the syringe pump and is only present when the instrument is operating with the front cover open. the instrument can operate with the front cover open during the "systems sequence test" mode for troubleshooting and/or maintenance.

Device

CLINITEK NOVUS AUTOMATED URINE CHEMISTRY ANALYZER (WITH RACK HANDLER)
  • Model / Serial
    Model Catalog: 10494134 (Lot serial: ALL LOTS); Model Catalog: 10844545 (Lot serial: ALL LOTS); Model Catalog: 10697937 (Lot serial: ALL LOTS); Model Catalog: 10844557 (Lot serial: ALL LOTS)
  • Product Description
    CLINITEK NOVUS AUTOMATED URINE CHEMISTRY ANALYZER (WITH RACK HANDLER)
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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