Events

Recall of ADVIA CENTAUR SYSTEM - PROSTATE-SPECIFIC ANTIGEN (PSA) 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
    100229
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-29
  • 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 is issuing a field safety notice to customers to emphasize that the prostate-specific antigen (psa) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. siemens is providing a limit of quantitation (loq) for the advia centaur psa assay at this time. the loq for psa on the advia centaur cp will follow.

Device

ADVIA CENTAUR SYSTEM - PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY
  • Model / Serial
    Model Catalog: 02676506 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 06574155 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    ADVIA CENTAUR SYSTEM - PSA ASSAY;ADVIA CENTAUR CP SYSTEM - PSA ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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