Events

Recall of ADVIA CHEMISTRY SYSTEMS - A1C_3 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
    73197
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-31
  • 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 advia chemistry systems hba1c method exhibits a positive bias of up to 12% for patient and cap survey samples due to over-recovery when using specific lots of a1c_3 calibrator. depending upon quality control limits this issue may not have been detected. this issue has been corrected beginning with a1c_3 calibrator lot 2ld017.

Device

ADVIA CHEMISTRY SYSTEMS - A1C_3 CALIBRATOR
  • Model / Serial
    Model Catalog: 10491408 (Lot serial: 1BD063); Model Catalog: 10491408 (Lot serial: 2GD014); Model Catalog: 10491408 (Lot serial: 1MD014)
  • Product Description
    ADVIA CHEMISTRY - A1C_3 CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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