BEUDAMED
    FDA Recall Terminated

    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

    Recall: Z-0838-2015 · Initiated November 5, 2014

    Recall

    Recall Number
    Z-0838-2015
    Event Number
    69687
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 5, 2014
    Posted
    December 20, 2014
    Terminated
    October 6, 2017
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

    Reason

    Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

    Action

    An Urgent Medical Device Correction, dated November 2014, was issued on November 4th, 2014 to inform customers that Siemens Healthcare Diagnostics has confirmed that reagent probe performance on Dimension Vista systems may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. Instructions for replacing an associated reagent probe were provided to resolve the issue. Customers are to retain the letter for their laboratory records and forward it to anyone who has received the affected product. Customers are also to complete and return the Field Correction Effectiveness Check Form. Customer should direct their questions to their Siemens Customer Care Center - Technical Solutions at 1-800-441-9250 or their local Siemens technical support representative.

    Distribution

    Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.

    Quantity

    1,949