Events

Recall of Device Recall Siemens ADVIA 560 Hematology Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc..

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
    73588
  • Event Risk Class
    Class 2
  • Event Number
    Z-1500-2016
  • Event Initiated Date
    2016-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144542
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Counter, differential cell - Product Code GKZ
  • Reason
    Software anomaly; siemens identified that software version 1.4.2133 on the advia 560 hematology system does not trigger the following flags: 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 t.
  • Action
    Siemens sent an Urgent Medical Device Correction Letter dated March 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. .Actions to be Taken by the Customer: To ensure that the patient sample amount for processing is met, follow the requirements for the amount of sample required in the ADVIA 560 Hematology System Operators Guide. Review all patient results for abnormal white blood cell results and process as defined by your lab criteria for abnormal samples and confirm using manual differentials as needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please review this letter with your Medical Director. Your Siemens Customer Service Engineer will contact you to schedule time for installation of the 1.4.2333 software when it is available. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (312) 275-7795.

Device

Device Recall Siemens ADVIA 560 Hematology Systems
  • Model / Serial
    All serial numbers of ADVIA 560 Hematology Systems.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of : Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.
  • Product Description
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD || The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA