Events

Recall of PHADIA 250 SYSTEM - ELIA CCP ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHADIA AB.

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
    20686
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-03
  • 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
    When using elia ccp well in combination with elia igg conjugate anti-ccp signals can be elevated. the positive bias will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.

Device

PHADIA 250 SYSTEM - ELIA CCP ASSAY
  • Model / Serial
    Model Catalog: 14-5515-01 (Lot serial: n/a); Model Catalog: 83-1017-01 (Lot serial: n/a); Model Catalog: 83-1040-01 (Lot serial: n/a)
  • Product Description
    PHADIA 250 SYSTEM - ELIA CCP ASSAY;PHADIA 250 SYSTEM - INSTRUMENT REAGENTS;PHADIA 100 SYSTEM - ELIA CCP
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB