Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - INSTRUMENT CLASS 2

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
    76746
  • Event Risk Class
    II
  • Event Initiated Date
    2013-12-19
  • 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
    In the advia 1200 chemistry system (software versions v2.00 and v2.01) and advia 1650 chemistry system (software versions v3.52 and v4.01) an overflow flag ///// is displayed in the result column for a test when the algorithm for that test cannot calculate a result or when the concentration of a test cannot be determined because it is outside the absorbance limits. ///// is not a usable or reportable result however it is possible for the user to misinterpret or edit this result.

Device

ADVIA 1200 CHEMISTRY SYSTEM - INSTRUMENT CLASS 2
  • Model / Serial
    Model Catalog: 094-A002-01 (Lot serial: CA12250023); Model Catalog: 02475632 (Lot serial: CA12250023); Model Catalog: M094-A002-01 (Lot serial: CA12250023); Model Catalog: 10309735 (Lot serial: CA12260020); Model Catalog: 094-A002-01 (Lot serial: CA12260020); Model Catalog: 02475632 (Lot serial: CA12260020); Model Catalog: M094-A002-01 (Lot serial: CA12260020); Model Catalog: 10309735 (Lot serial: CA12260019); Model Catalog: 094-A002-01 (Lot serial: CA12260019); Model Catalog: 02475632 (Lot serial: CA12260019); Model Catalog: M094-A002-01 (Lot serial: CA12260019); Model Catalog: 10309735 (Lot serial: CA12240082); Model Catalog: 094-A002-01 (Lot serial: CA12240082); Model Catalog: 02475632 (Lot serial: CA12240082); Model Catalog: M094-A002-01 (Lot serial: CA12240082); Model Catalog: 10309735 (Lot serial: CA12250088); Model Catalog: 094-A002-01 (Lot serial: CA12250088); Model Catalog: 02475632 (Lot serial: CA12250088); Model Catalog: M094-A002-01 (Lot serial: CA12250088); Model Catalog: 094-A002-01 (Lot serial
  • Product Description
    ADVIA 1200 CHEMISTRY SYSTEM INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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