Events

Recall of ADVIA CENTAUR XPT INSTRUMENT

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
    84908
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-27
  • 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 identified multiple issues with advia centaur xpt system software versions v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) v1.0.3 (bundle 1.0.1108 smn 11220781) and v1.1 (bundle 1.1.243 smn 11221979). these issues may affect the results generated by the system and are described below: 1. sample tip error 2. daily maintenance 3. result reporting for high/low linearity samples 4. auto-repeat conditions 5. barcode misreads in rack id mode 6. low probe wash 7. las communication 8. system status unknown.

Device

ADVIA CENTAUR XPT INSTRUMENT
  • Model / Serial
    Model Catalog: 10711433 (Lot serial: ALL)
  • Product Description
    Advia centaur XPT Instrument
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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