Events

Recall of ADVIA CENTAUR CP SYSTEM - CA 125II 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
    126636
  • Event Risk Class
    III
  • Event Initiated Date
    2018-02-23
  • 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 is issuing a communication to advise that some patient samples exhibit sample specific dilution over-recovery outside of the representative dilution recovery data provided in the advia centaur ca 125ii assay instruction for use. investigations performed by siemens healthcare diagnostics demonstrated dilution recoveries up to 140% with certain patient samples. studies indicate the dilution over-recovery is patient sample specific. the advia centaur ca 125ii assay instruction for use will be updated to include a statement refering to the potential for sample specific non-linear dilution. the performance of the advia centaur ca 125ii assay has not changed.

Device

ADVIA CENTAUR CP SYSTEM - CA 125II ASSAY
  • Model / Serial
    Model Catalog: 01678114 (Lot serial: >100 numbers contact mfg); Model Catalog: 09427226 (Lot serial: >100 numbers contact mfg)
  • Product Description
    ADVIA CENTAUR CP SYSTEM - CA 125II ASSAY;ADVIA CENTAUR SYSTEM - CA 125 II ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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