Events

Recall of IQ 200 SELECT PLUS

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
    22821
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-14
  • 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
    Iris international has determined that the iq200 series urine microscopy analyzer with barcode reader (model nft-2100) may intermittently exhibit the following: - failure to read the urine sample dilution barcode label where it defaults to a dilution factor of 1:1 and does not apply the correct dilution factor. - failure to read body fluid dilution barcode label where the rack is rejected and no results are generated.

Device

IQ 200 SELECT PLUS
  • Model / Serial
    Model Catalog: 800-3935 (Lot serial: 8057); Model Catalog: 800-3935 (Lot serial: 8089); Model Catalog: 800-3935 (Lot serial: 8324); Model Catalog: 800-3935 (Lot serial: 5883); Model Catalog: 800-3935 (Lot serial: 5938); Model Catalog: 800-3935 (Lot serial: 5985); Model Catalog: 800-3935 (Lot serial: 6215); Model Catalog: 800-3052 (Lot serial: 6996); Model Catalog: 800-3052 (Lot serial: 9817); Model Catalog: 800-3052 (Lot serial: 3999); Model Catalog: 800-3052 (Lot serial: 7305); Model Catalog: 800-3052 (Lot serial: 7831); Model Catalog: 800-3934 (Lot serial: 6996); Model Catalog: 800-3934 (Lot serial: 9817); Model Catalog: 800-3934 (Lot serial: 7305); Model Catalog: 800-3934 (Lot serial: 7831); Model Catalog: 700-3322 (Lot serial: N/A); Model Catalog: 800-3934 (Lot serial: 3999); Model Catalog: 800-3051 (Lot serial: N/A); Model Catalog: 800-3920 (Lot serial: N/A); Model Catalog: 800-3053 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 800-3933 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 800-3
  • Product Description
    IQ 200 SELECT PLUS;IQ 200 ELITE PRO;IQ 200 ELITE PLUS;IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER;IQ 200 SELECT PRO;IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER;IQ 200 SPRINT PRO;IQ 200 SPRINT PLUS;IQ200 SELECT URINALYSIS SYSTEM - ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.