Events

Recall of PHADIA 250 SYSTEM - INSTRUMENT

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
    121077
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-01
  • 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
    Erroneous results may occur as a result of a software issue when specific conditions occur with the phadia 250. the issue can occur with all versions of the phadia prime software up to and including version 2.1.4. the issue will cause software to disregard default dilution factors for rejected samples when using the "ok to all" function for retesting of samples if specific criteria are met.

Device

PHADIA 250 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 12-3900-01 (Lot serial: N01127); Model Catalog: 12-3900-01 (Lot serial: N02768); Model Catalog: 12-3900-01 (Lot serial: N02077); Model Catalog: 12-3900-01 (Lot serial: N02617); Model Catalog: 12-3900-01 (Lot serial: N10109); Model Catalog: 12-3900-01 (Lot serial: N01902); Model Catalog: 12-3900-01 (Lot serial: N02243); Model Catalog: 12-3900-01 (Lot serial: N02295); Model Catalog: 12-3900-01 (Lot serial: N02770 / N02771); Model Catalog: 12-3900-01 (Lot serial: N10054); Model Catalog: 12-3900-01 (Lot serial: N10088); Model Catalog: 12-3900-01 (Lot serial: N10070)
  • Product Description
    Phadia 250 Instrument (including software)
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB