Events

Recall of ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD

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
    35655
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-15
  • 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 confirmed the ichemvelocity automated urine chemistry system does not maintain the on-board strip stability of 5 days at 18-28 degrees c at 20-80% relative humidity (rh) as stated in the ichemvelocity product labeling. the on-board strip stability is affected by temperature and humidity in the laboratory. if a laboratory operates outside of the parameters defined in table 1 of the urgent medical device recall letter test results may be affected as indicated below: - false low or false negative results: ketone blood - false high or false positive results: bilirubin glucose leukocytes - false high results: urobilinogen ascorbic acid protein ph and nitrite are not affected.

Device

ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
  • Model / Serial
    Model Catalog: 800-7167 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 800-7719 (Lot serial: V03266); Model Catalog: 800-7719 (Lot serial: V03263); Model Catalog: 800-7719 (Lot serial: V02850); Model Catalog: 800-7719 (Lot serial: V01384); Model Catalog: 800-7719 (Lot serial: V02800); Model Catalog: 800-7719 (Lot serial: V02781); Model Catalog: 800-7719 (Lot serial: V03301); Model Catalog: 800-7719 (Lot serial: V02564)
  • Product Description
    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W/LOAD/UNLOAD
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.