Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - 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
    33252
  • Event Risk Class
    III
  • Event Initiated Date
    2014-08-07
  • 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
    Multiple customer complaints were received reporting hba1c bias on patient samples and for cap survey failures when using a1c_3 calibrator lots 3hd044 3ld068. siemens has confirmed a -9% to -11% bias on these calibrator lots. the quality control values although high biased recover within assigned ranges - therefore may not detect the issue. an internal complaint was also generated for ngsp certification failure due to a low bias.

Device

ADVIA 1200 CHEMISTRY SYSTEM - A1C_3 CALIBRATOR
  • Model / Serial
    Model Catalog: 10491408 (Lot serial: 3HD044); Model Catalog: 10491408 (Lot serial: 3LD068)
  • Product Description
    ADVIA 1200 CHEMISTRY SYSTEM - A1C_3 CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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