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
    149525
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-01
  • 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
    An internal product review determined that there was an issue with software versions 2.60/2.4.0.0 and 2.61/2.4.1.0 for the clinitek status+ connect systems which could potentially affect patient results. in the case that an operator transmits all of the data stored in the instrument to an lis or data manager by selecting the "send all" function the software will allow the operator to perform a urinalysis strip or cassette test while data is still being transferred. in this case the instrument may be slow to respond. depending on the amount of data being transferred and the speed at which it is transferred there may be a delay in timing when the urinalysis reagents are read by the analyzer. this delay in read time may potentially affect patient results.

Device

CLINITEK STATUS SYSTEM - URINE CHEMISTRY ANALYZER
  • Model / Serial
    Model Catalog: CLINITEK STATUS+ (Lot serial: SW versions 2.61); Model Catalog: CLINITEK STATUS+ (Lot serial: SW versions 2.60)
  • Product Description
    CLINITEK Status+
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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