Events

Recall of ADVIA 560 HEMATOLOGY ANALYZER

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
    53042
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-11
  • 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 identified that software version 1.4.2133 does not trigger the following flags: - the w warning flag for detecting small sample volumes when using the international software configuration. if there is not enough sample volume of the patient's blood when the sample is run results may be lower than expected. this can occur if the required sample volume as defined in the advia 560 hematology system operator's guide is not followed. - the g or l morphology flags for immature granulocytes (ig) and atypical lymphocytes (atyp) respectively. the results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. as defined in the advia 560 hematology system operator's guide the immature granulocytes and atypical lymphocyte morphology flags should be raised when the presence of morphologically abnormal cells is suspected indicating that a manual count on a stained smear needs to be performed.

Device

ADVIA 560 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 11170842 (Lot serial: S020099)
  • Product Description
    ADVIA 560 HEMATOLOGY ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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