Events

Recall of CLINITEK NOVUS AUTOMATED URINE CHEMISTRY ANALYZER (WITHOUT 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
    78479
  • Event Risk Class
    III
  • Event Initiated Date
    2015-01-28
  • 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
    Potential reporting error with the clinitek novus analyzer when using the novus pro 12 urinalysis cassette. when albumin creatine or protein displays an"err" message when clinitek novus pro12 urinalysis cassette is used the clinitek novus analyzer may still report p:c or a:c ratio value.

Device

CLINITEK NOVUS AUTOMATED URINE CHEMISTRY ANALYZER (WITHOUT RACK HANDLER)
  • Model / Serial
    Model Catalog: 10844557 (Lot serial: All Lots); Model Catalog: 10697937 (Lot serial: All Lots); Model Catalog: 10844545 (Lot serial: ALL LOTS); Model Catalog: 10494134 (Lot serial: ALL LOTS)
  • Product Description
    Clinitek Novus Urine Chemistry Analyzer
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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