Events

Recall of ADVIA CENTAUR XP SYSTEM - CALIBRATORS

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
    21197
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-29
  • 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
    Calibrator e is used for calibration of the advia centaur systems cortisol progesterone and testosterone assays. siemens healthcare diagnostics has identified a positive bias for calibrator e kit lots ending in 38 and 39 with the advia centaur systems cortisol and progesterone assays compared to the respective master curves. patient serum samples evaluated with the advia centaur cortisol assay and calibrated with calibrator e kit lots listed in table 1 demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. patient serum samples evaluated with the advia centaur systems progesterone assay and calibrated with calibrator e kit lots ending in 38 and 39 demonstrate a positive bias with samples above 30 ng/ml. the average positive bias on the advia centaur/advia centaur xp is 20% with a maximum bias of 39%. the average positive bias on the advia centaur cp is 17% with a maximum bias of 35%. the advia centaur systems testosterone assay is not affected by this correction.

Device

ADVIA CENTAUR XP SYSTEM - CALIBRATORS
  • Model / Serial
    Model Catalog: 04634762 (Lot serial: >10 contact mfg.); Model Catalog: 04634452 (Lot serial: >10 contact mfg.); Model Catalog: 04636889 (Lot serial: >10 contact mfg.)
  • Product Description
    Advia Centaur XP System - Calibrator E
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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