Events

Recall of UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - PAPP-A 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
    92469
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-07
  • 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 inc. (bec) has identified that two access papp-a quality control (qc) lots (120380 122262) may generate mean values below the mean values stated on the qc cards. the average difference observed in bec's internal investigation was 11% below the stated mean. the results observed may vary based on the combination of reagent and calibrator lots in use. reduced qc could lead to repeat testing and a potential delay in reporting patient results.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - PAPP-A ASSAY
  • Model / Serial
    Model Catalog: A48573 (Lot serial: 122262); Model Catalog: A48573 (Lot serial: 120380)
  • Product Description
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - PAPP-A ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.