Events

Recall of Prostate Specific Antigen (PSA) Semi-Quantitative Rapid Test (Whole Blood/Serum/Plasma); Prostate Sepicific Antigen (PSA) Semi-Quantitative Ultra Rapid Test (Whole Blood/Serum/Plasma

According to Valvira - National Supervisory Authority for Welfare and Health (via FOI), this recall involved a device in Finland that was produced by Innovacon, 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
    2009-0690
  • Date
    2009-07-28
  • Event Country
    Finland
  • Event Source
    VNSAWH
  • Notes / Alerts
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Extra notes in the data
    Source: MDV DE
  • Reason
    Device failure / feature before use - material / component.

Device

Prostate Specific Antigen (PSA) Semi-Quantitative Rapid Test (Whole Blood/Serum/Plasma); Prostate...

Manufacturer

Innovacon, Inc.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    VNSAWH