Events

Recall of DELFIA XPRESS 6000 IMMUNOANALYZER SYSTEM - FREE HCGB ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PERKINELMER HEALTH SCIENCES CANADA INC..

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
    68675
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-23
  • 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
    Manufacturer became aware of the incorrectness of the barcode in the label of free hcgb assay buffer vial. due to the error in the barcode 6000 delfia xpress instrument cannot read the information from the barcode. the information in the label cannot be entered manually in the instrument and therefore the customer cannot use the affected vials.

Device

DELFIA XPRESS 6000 IMMUNOANALYZER SYSTEM - FREE HCGB ASSAY
  • Model / Serial
    Model Catalog: 6002-0010 (Lot serial: 1063303806)
  • Product Description
    DELFIA XPRESS 6000 IMMUNOANALYZER SYSTEM - FREE HCGB ASSAY
  • Manufacturer
    PERKINELMER HEALTH SCIENCES CANADA INC.

Manufacturer

PERKINELMER HEALTH SCIENCES CANADA INC.
  • Manufacturer Address
    WOODBRIDGE
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    HC