Events

Recall of ADVIA CENTAUR CP SYSTEM - CALIBRATOR

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
    127762
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-03
  • 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
    The high calibrator for calibrator a lot ca77 is under-recovering to the assigned target for the advia centaur total t4 assay. internal investigations showed that the average bias of the high calibrator-to-target is -20% with an observed range of bias from -21% to -19%. the under-recovery of the high calibrator is leading to an elevated response in the high end of the total t4 assay which may be reflected in level 3 quality controls (15.8ug/dl for biorad lyphochek control level (40243)) being out of range high. internal investigations showed that the average bias of the level 3 control-to-target is 16% which had an observed range of bias from 10% to 20%.

Device

ADVIA CENTAUR CP SYSTEM - CALIBRATOR
  • Model / Serial
    Model Catalog: 04800840 (Lot serial: 90705A77); Model Catalog: 04800735 (Lot serial: 90705A77); Model Catalog: 04800735 (Lot serial: 90669A77); Model Catalog: 04800840 (Lot serial: 90669A77); Model Catalog: 04800840 (Lot serial: 89983A77); Model Catalog: 04800735 (Lot serial: 89983A77)
  • Product Description
    ADVIA CENTAUR CP SYSTEM-CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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