Events

Recall of ADVIA CENTAUR CP SYSTEM - THYROXINE (T4) 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
    61012
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-24
  • 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 healthcare diagnostics is currently investigating confirmed reports of calibration slope failures on various lots of the advia centaur systems t4 reagent. a failed calibration slope will result in an invalid calibration status which will prevent t4 patient results from being generated. if the calibration slope passes and controls are within laboratory limits patient results are considered valid and may be reported.

Device

ADVIA CENTAUR CP SYSTEM - THYROXINE (T4) ASSAY
  • Model / Serial
    Model Catalog: 110736 (Lot serial: > 10 contact mfg); Model Catalog: 110735 (Lot serial: >10 contact mfg.); Model Catalog: 110736 (Lot serial: >10 contact mfg.); Model Catalog: 110735 (Lot serial: > 10 contact mfg)
  • Product Description
    ADVIA CENTAUR CP SYSTEM - THYROXINE (T4) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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