Events

Recall of CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM - NEGATIVE CONTROL STRIPS

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
    78731
  • Event Risk Class
    III
  • Event Initiated Date
    2016-01-26
  • 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
    There is a potential issue when entering the clinitek atlas control lot information into the clinitek novus analyzer for the bottle lot numbers p0001105 p0003115 n0006115. this is due to a missing alpha character at the end of the lot number on the control bottles for example: lot p0001105 instead of p0001105x.

Device

CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM - NEGATIVE CONTROL STRIPS
  • Model / Serial
    Model Catalog: 10311135 (Lot serial: N0006115); Model Catalog: 10311124 (Lot serial: P0001105); Model Catalog: 10311124 (Lot serial: P0003115)
  • Product Description
    CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM-NEGATIVE CONTROL STRIPS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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