Events

Recall of ADVIA CENTAUR SYSTEM - INSULIN 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
    136289
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-10
  • 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 has identified that current in-date lots of advia centaur systems insulin assay recover approximately 40% higher than the world health organization (who) 1st irp 66/304 standardization based on slope values. the slope value was 1.40 on the advia centaur and 1.42 on the advia centaur cp. corrected (re-standardized) lots will be available by may 2017.

Device

ADVIA CENTAUR SYSTEM - INSULIN ASSAY
  • Model / Serial
    Model Catalog: 04618899 (Lot serial: 11624A74); Model Catalog: 04618899 (Lot serial: 11615A70); Model Catalog: 02230141 (Lot serial: 11090173); Model Catalog: 04618899 (Lot serial: 16546174); Model Catalog: 02230141 (Lot serial: 16546174); Model Catalog: 04618899 (Lot serial: 04177173); Model Catalog: 02230141 (Lot serial: 04177173); Model Catalog: 04618899 (Lot serial: 90517170); Model Catalog: 02230141 (Lot serial: 90517170); Model Catalog: 04618899 (Lot serial: 75853169); Model Catalog: 02230141 (Lot serial: 75853169); Model Catalog: 04618899 (Lot serial: 61612169); Model Catalog: 02230141 (Lot serial: 61612169); Model Catalog: 04618899 (Lot serial: 11606A67); Model Catalog: 02230141 (Lot serial: 11606A67); Model Catalog: 04618899 (Lot serial: 11587A59); Model Catalog: 02230141 (Lot serial: 11587A59); Model Catalog: 04618899 (Lot serial: 11090173); Model Catalog: 02230141 (Lot serial: 11615A70); Model Catalog: 02230141 (Lot serial: 11624A74)
  • Product Description
    ADVIA CENTAUR SYSTEM - INSULIN ASSAY;ADVIA CENTAUR CP SYSTEM - INSULIN ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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