Events

Recall of DIMENSION CHEMISTRY SYS- (TPSA)TOTAL PROSTATE SPECIFIC ANTIGEN FLEX REAGENT

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
    121634
  • Event Risk Class
    II
  • Event Initiated Date
    2008-04-02
  • 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
    Some reagent cartridge lots exhibit imprecision that may cause falsely elevated results of up to 0.2 ng/ml have been confirmed by internal testing at concentrations between 0.0 and 0.3 ng/ml.

Device

DIMENSION CHEMISTRY SYS- (TPSA)TOTAL PROSTATE SPECIFIC ANTIGEN FLEX REAGENT
  • Model / Serial
    Model Catalog: RF451 (Lot serial: GB9029); Model Catalog: RF451 (Lot serial: GB9021)
  • Product Description
    DIMENSION TPSA FLEX REAGENT CARTRIDGE
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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