Events

Recall of UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - GI MONITOR (CA 19-9)

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
    22302
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-09
  • 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 through internal investigation and customer feedback that the affected assays are susceptible to biotin interference with patient samples containing 100 ng/ml of biotin. specimens that contain high levels of biotin may cause: false low results for the access gi monitor and thyroglobulin assays and may cause false high results for the access free t4 and total t3 assays.

Device

UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - GI MONITOR (CA 19-9)
  • Model / Serial
    Model Catalog: 387687 (Lot serial: ALL LOTS); Model Catalog: 33830 (Lot serial: ALL LOTS); Model Catalog: 33860 (Lot serial: ALL LOTS); Model Catalog: 33880 (Lot serial: ALL LOTS)
  • Product Description
    387687 GI MONITOR (UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM);33830 TOTAL T3 (UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM);33860 THYROGLOBULIN (UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM);33880 FREE T4 (UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM);33880 FREE T4 (A
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.