Events

Recall of DIMENSION VISTA SYSTEM - TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY

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

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
    16545
  • Event Risk Class
    II
  • Event Initiated Date
    2012-04-03
  • 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
    Siemens has confirmed a report of leaking flex reagent cartridges from tpsa lot 113300bb. if a leaking flex reagent cartridge is used test may be falsely depressed. the magnitude of the inaccuracy and the number of test results affected may vary based on the extent of leaking.

Device

DIMENSION VISTA SYSTEM - TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY
  • Model / Serial
    Model Catalog: K6451 (Lot serial: 11300BB)
  • Product Description
    DIMENSION VISTA SYSTEM-TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC