Events

Recall of ADVIA CENTAUR SYSTEM - TOBRAMYCIN 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
    24426
  • Event Risk Class
    III
  • Event Initiated Date
    2011-10-04
  • 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
    Reagents of specified lots failed qc requirements while within the assay stored calibration and onboard stability claims of 7 and 14 days respectively. this issue is detected through routine qc monitoring where results are out of the expected range values resulting in the failure of the tobramycin assay to meet the onboard stability claim.

Device

ADVIA CENTAUR SYSTEM - TOBRAMYCIN ASSAY
  • Model / Serial
    Model Catalog: 03329524 (Lot serial: ); Model Catalog: 00835186 (Lot serial: ); Model Catalog: 00835186 (Lot serial: 20 LOT NUMBERS CONTACT MFR); Model Catalog: 03329524 (Lot serial: 20 LOT NUMBERS CONTACT MFR)
  • Product Description
    TOBRAMYCIN ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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