Events

Recall of UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - AFP 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
    18921
  • Event Risk Class
    III
  • Event Initiated Date
    2010-04-21
  • 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 afp qc kits contain three levels of control material identified as qc1 qc2 and qc3. beckman coulter has confirmed that vials of qc1 in certain kit lots contain microbial contamination.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - AFP ASSAY
  • Model / Serial
    Model Catalog: 33219 (Lot serial: 911581); Model Catalog: 33219 (Lot serial: Access Immunoassay); Model Catalog: 33219 (Lot serial: 911158); Model Catalog: 33219 (Lot serial: Systems AFP QC)
  • Product Description
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM-AFP ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.