Events

Recall of DIMENSION CLINICAL CHEMISTRY SYSTEM - PROSTRATE SPECIFIC ANTIGEN PSA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DADE BEHRING 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
    96246
  • Event Risk Class
    II
  • 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
    About 1-5% of samples using these affected lot numbers may exhibit psa values that are falsely elevated by approximately 0.2 to 3.0 ng/ml.

Device

DIMENSION CLINICAL CHEMISTRY SYSTEM - PROSTRATE SPECIFIC ANTIGEN PSA
  • Model / Serial
    Model Catalog: RF450 (Lot serial: TC1174); Model Catalog: RF450 (Lot serial: AR1010); Model Catalog: RF450 (Lot serial: CP1068); Model Catalog: RF450 (Lot serial: IR1265)
  • Product Description
    DIMENSION FLEX FOR PROSTRATE SPECIFIC
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

DADE BEHRING CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC