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
    22397
  • Event Risk Class
    III
  • Event Initiated Date
    2010-12-17
  • 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 confirmed that kit lot 012781(vial lots: qc1:012778 qc2: 012779 and qc3: 012780) of access afp qc may contain a precipitate in all three qc levels included in the kit.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - AFP ASSAY
  • Model / Serial
    Model Catalog: 33219 (Lot serial: 012781 ACCESS AFP QC KIT)
  • Product Description
    ACCESS IMMUNOASSAY SYSTEMS ALPHA-FETOPROTEIN(AFP) QC KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.