Events

Recall of ACCESS IMMUNOASSAY SYSTEM - BR MONITOR (CA 15-3) 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
    74837
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-14
  • 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
    Following biases observed in the results of the french national quality controls beckman coulter has been informed that a study completed by the french competent authority agence nationale de securite du medicament et des produits de sante (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).

Device

ACCESS IMMUNOASSAY SYSTEM - BR MONITOR (CA 15-3) ASSAY
  • Model / Serial
    Model Catalog: 387620 (Lot serial: Future Lots); Model Catalog: 387620 (Lot serial: All Non-Expired Lots and)
  • Product Description
    ACCESS IMMUNOASSAY SYSTEM - BR MONITOR (CA 15-3) ASSAY;UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - BR MONITOR (CA 15-3) ASSAY;UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - BR MONITOR (CA 15-3) ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.