Events

Recall of ADVIA CHEMISTRY SYSTEM - ADVIA 1650 ANALYZER - CLASS 2

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
    19599
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-06
  • 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 confirmed that the affected devices will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. in cases where an error flag suppresses a numerical result a ratio calculation will not be performed. if a numerical result is generated with a flag the ratio will be reported without a flag.

Device

ADVIA CHEMISTRY SYSTEM - ADVIA 1650 ANALYZER - CLASS 2
  • Model / Serial
    Model Catalog: 10324237 (Lot serial: ALL); Model Catalog: 06363413 (Lot serial: ALL); Model Catalog: 073-B002-01 (Lot serial: ALL); Model Catalog: 10315769 (Lot serial: ALL); Model Catalog: 073-A011-02 (Lot serial: ALL); Model Catalog: 01714935 (Lot serial: ALL); Model Catalog: 01412173 (Lot serial: ALL); Model Catalog: 094-A002-01 (Lot serial: ALL); Model Catalog: 10309735 (Lot serial: ALL); Model Catalog: 02475632 (Lot serial: ALL); Model Catalog: 10315183 (Lot serial: ALL); Model Catalog: 073-A021-01 (Lot serial: ALL); Model Catalog: M094-A002-01 (Lot serial: ALL)
  • Product Description
    ADVIA CHEMISTRY SYSTEM-ADVIA 1650 ANALYZER - CLASS 2
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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