Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - LIQUID SPECIFIC PROTEIN CALIBRATORS

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
    78920
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-06
  • 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 health care diagnostics has confirmed two issues with the siemens liquid specific protein calibrator lot 303574. issue 1: increased frequency of max fit deviation flags using the liquid specific protein (lsp) calibrator kit lot 303574 (vial lots 122it-127it) to calibrate the alpha-1-antitrypsin (att) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems aat assay. issue 2: siemens confirmed that the preliminary version of the siemens lsp calibrator lot-specific instructions for use (ifu) for calibrator kit lot 303574 resided in the siemens document library from dec.10 2013 until apr.07 2014. the lsp calibrator preliminary factor values during this time differed slightly from the final factor values for the following advia chemistry stystem assays: aag aat aso_2 c3 c4 frt hapt iga_2 igg_2 igm_2 prealb rf and trf. the ifu insert packaged in the siemens lsp calibrator kit lot 303574 always contained the correct values for all those assays except aat. the ifu that is currently in the kit and the ifu that was in the siemens document library from apr.07 2014 to oct.30 2014 does not reflect the updated aat calibrator value for lsp calibrator level 2. as of oct.31 2014 all of the final lsp calibrator values are correct on the siemens document library. when using either the final or preliminary calibrator values quality control results recover well within the manufacturer's specified upper and lower ranges and patient sample results did not demonstrate clinically significant differences.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LIQUID SPECIFIC PROTEIN CALIBRATORS
  • Model / Serial
    Model Catalog: 07711199 (Lot serial: 303574)
  • Product Description
    ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrator
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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