Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - DRUGS OF ABUSE CALIBRATOR

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
    24760
  • Event Risk Class
    III
  • Event Initiated Date
    2015-01-21
  • 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
    Manufacturer has determined that incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i lot 3jd018 for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays. this issue was determined to be the result of calibrator value miscalculation. calibrator lot 3jd018 has now been value assigned to align with the correct calibrator values. internal investigation concluded that quality control results still recover within the manufacturer's ranges when using either the incorrect or corrected calibrator values. there is no change to the calibrator values for the advia chemistry systems theophylline 2 (theo_2) assay.

Device

ADVIA 1200 CHEMISTRY SYSTEM - DRUGS OF ABUSE CALIBRATOR
  • Model / Serial
    Model Catalog: 10376770 (Lot serial: 3JD018)
  • Product Description
    ADVIA Chemistry Systems Drug Calibrator I
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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