Events

Recall of IQ200 SELECT URINALYSIS SYSTEM - ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    42045
  • Event Risk Class
    II
  • Event Initiated Date
    2018-03-05
  • 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
    Beckman coulter has determined that there is a potential for under-reporting casts. this can occur if per high-power field (/hpf) units of measurement for casts are selected in the iq200 software but the abnormal threshold and/or grading format is set up based on reporting "per low-power field (/lpf)" or "per microliter (/ul). this may occur during initial method validation or if settings are altered after the initial validation.

Device

IQ200 SELECT URINALYSIS SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: 800-3900 (Lot serial: ALL); Model Catalog: 800-3053 (Lot serial: ALL); Model Catalog: 800-3933 (Lot serial: ALL); Model Catalog: 800-3934 (Lot serial: ALL); Model Catalog: 700-3322 (Lot serial: ALL); Model Catalog: 800-3051 (Lot serial: ALL); Model Catalog: 800-3920 (Lot serial: ALL); Model Catalog: 800-3052 (Lot serial: ALL); Model Catalog: 800-3935 (Lot serial: ALL)
  • Product Description
    IQ200 SELECT URINALYSIS SYSTEM - ANALYZER;IQ 200 SPRINT PRO;IQ 200 SPRINT PLUS;IQ 200 ELITE PLUS;IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER;IQ 200 SELECT PRO;IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER;IQ 200 ELITE PRO;IQ 200 SELECT PLUS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.