BEUDAMED
    FDA Recall Terminated

    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.

    Recall: Z-1957-2015 · Initiated May 19, 2015

    Recall

    Recall Number
    Z-1957-2015
    Event Number
    71362
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 19, 2015
    Posted
    July 2, 2015
    Terminated
    April 27, 2018
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.

    Reason

    Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.

    Action

    Siemens sent an Urgent Medical Device Correction letter dated May 19, 2015, 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 When using any of the CentraLink sample queries, do not select Instrument or Instrument Group criteria for Dimension Vista 500 or Dimension Vista 1500. This would also include any preconfigured queries, commands or tool bar buttons that may use these criteria. Your local Siemens service provider will be contacting you to verify and/or update the configuration of your CentraLink system. 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 (800) 441-9250.

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom.

    Quantity

    1941