BEUDAMED
    FDA Recall Open, Classified

    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    Recall: Z-1398-2021 · Initiated March 5, 2021

    Recall

    Recall Number
    Z-1398-2021
    Event Number
    87488
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    GKZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 5, 2021
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

    Reason

    Potential Sample Identification (SID) Mismatch with14-Character Barcodes

    Action

    Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter HSW21-01.A.US to US customers on March 5, 2021 via FedEx overnight delivery. An Urgent Field Safety Notice (UFSN) HSW21-01.A.OUS was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: with your Medical Director. If you are using 14-character Sample Identification (SID) barcodes: o Ensure that the Barcode Encoding Selectivity feature is enabled. Open the Sample Identification screen to determine if the checkbox to turn the Barcode Encoded Selectivity is on o If Barcode Encoding Selectivity is disabled, please perform the following steps to enable Barcode Encoding Selectivity: Open the Sample Identification screen Select the checkbox to turn the Barcode Encoded Selectivity on Whether or not you have the Barcode Encode Selectivity feature disabled, please complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿ao Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mali Malta, Martinique, Mexico, Namibia, Netherlands, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.

    Quantity

    195 units