Events

Recall of ADVIA CENTAUR CP SYSTEM - CA 19-9 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
    21376
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-19
  • 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 diagnostic has observed a system to system bias between teh ca 19-9 assay on teh advia centaurj cp and advia centaur xp/avida centatur xpt systems with the advis centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system for patient samples. siemes is actively pursuing the cause of this issue.

Device

ADVIA CENTAUR CP SYSTEM - CA 19-9 ASSAY
  • Model / Serial
    Model Catalog: 10491244 (Lot serial: kits ending in 384); Model Catalog: 10491379 (Lot serial: kits ending in 380); Model Catalog: 10491244 (Lot serial: kits ending in 382); Model Catalog: 10491244 (Lot serial: kits ending in 380); Model Catalog: 10491379 (Lot serial: kits ending in 390); Model Catalog: 10491244 (Lot serial: kits ending in 390); Model Catalog: 10491379 (Lot serial: kits ending in 388); Model Catalog: 10491244 (Lot serial: kits ending in 388); Model Catalog: 10491379 (Lot serial: kits ending in 386); Model Catalog: 10491244 (Lot serial: kits ending in 386); Model Catalog: 10491379 (Lot serial: kits ending in 384); Model Catalog: 10491379 (Lot serial: kits ending in 382)
  • Product Description
    AVIDA Centaur CP system- CA 19-9 Assay;ADVIA Centaur system- CA19-9 Assay
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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