Events

Recall of ADVIA CENTAUR 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
    25695
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-12
  • 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 has confirmed a negative bias for advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur advia centaur xp and advia centaur xpt systems. in addition siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected. customers may continue to use calibrator a kit lots ending in 90 for the advia centaur systems ft3 t3 t4 and tup assays. internal investigations were performed using available ft4 lots. the investigation confirmed an overall negative bias when comparing calibrator a kit lots ending in 90 to previously released calibrator a kit lots ending in 89. in some instances the negative bias may cause euthyroid patient samples to result low and outside the reference interval listed in the instructions for use (ifu). quality control material and master curve material may result low and outside acceptable ranges.

Device

ADVIA CENTAUR SYSTEM - CALIBRATORS
  • Model / Serial
    Model Catalog: 04800735 (Lot serial: >10 LOT NUMBERS CONTACT MFR); Model Catalog: 04800646 (Lot serial: >10 LOT NUMBERS CONTACT MFR)
  • Product Description
    ADVIA CENTAUR SYSTEM-CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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