Events

Recall of ICHEM VELOCITY URINE CHEMISTRY STRIPS

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
    34936
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-05
  • 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
    Iris diagnostics has become aware of a strip manufacturing error where an incorrect pad was inadvertently placed in the location of the leukocytes pad. all other analytes are correct. this defect exists on a subset of vials belonging to lot 7212154 a with the impacted vial numbers ranging from 01520 through 02401.

Device

ICHEM VELOCITY URINE CHEMISTRY STRIPS
  • Model / Serial
    Model Catalog: 800-7212 (Lot serial: Lot # 7212154 A)
  • Product Description
    iChemVELOCITY Urine Chemistry Strips
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.