Events

Recall of UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - FREE PSA ASSAY

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
    97609
  • Event Risk Class
    III
  • Event Initiated Date
    2011-10-14
  • 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
    Access hybritech free psa reagent ref 37210 all lots: the instructions for use indicates patient samples that are elevated beyond the measuring range of the assay can be manually diluted using access hybritech free psa calibrator s0 or wash buffer ii to determine absolute sample concentration. wash buffer ii is also used with the unicel dxi onboard dilution feature for diluting patient samples. beckman coulter has identified a positive bias in test results when comparing elevated free psa patient samples diluted with wash buffer ii to samples diluted with access hybritech free psa calibrtor s0.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - FREE PSA ASSAY
  • Model / Serial
    Model Catalog: 37210 (Lot serial: ALL)
  • Product Description
    ACCESS HYBRITECH FREE PSA
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.