Recall of ADVIA CHEMISTRY SYSTEM - ADVIA 1650 ANALYZER - 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
    30164
  • Event Risk Class
    III
  • Event Initiated Date
    2013-11-11
  • Event Country
  • 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 confirms that three issues were identified where the system may pass calibration and qc when it should not. these include auto-calibration with flagged system related errors auto-calibration with a lot change and reagent pack switching mid-calibration or mid-qc. users are being advised when any of the three situations occur to perform the calibration or qc again.

Device

  • Model / Serial
    Model Catalog: 073-B002-01 (Lot serial: CA175542364); Model Catalog: 06363413 (Lot serial: CA175542364); Model Catalog: 10309735 (Lot serial: CA175542364); Model Catalog: 01714935 (Lot serial: >10 numbers contact mfg.); Model Catalog: 073-A011-02 (Lot serial: >10 numbers contact mfg.); Model Catalog: 10315769 (Lot serial: >10 numbers contact mfg.); Model Catalog: 094-A002-01 (Lot serial: CA12260020); Model Catalog: M094-A002-01 (Lot serial: CA12260038); Model Catalog: 10309735 (Lot serial: CA12260038); Model Catalog: 094-A002-01 (Lot serial: CA12260038); Model Catalog: 02475632 (Lot serial: CA12260038); Model Catalog: M094-A002-01 (Lot serial: CA12250023); Model Catalog: 10309735 (Lot serial: CA12250023); Model Catalog: 094-A002-01 (Lot serial: CA12250023); Model Catalog: 02475632 (Lot serial: CA12250023); Model Catalog: M094-A002-01 (Lot serial: CA12260020); Model Catalog: 10309735 (Lot serial: CA12260020); Model Catalog: 01412173 (Lot serial: >10 numbers contact mfg); Model Catalog: 02475632 (Lot serial: C
  • Product Description
    ADVIA CHEMISTRY SYSTEM-ADVIA 1650 ANALYZER
  • Manufacturer

Manufacturer

  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
  • Source
    HC