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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA 2120i with Single Aspirate Autosampler

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  Class 2 Device Recall ADVIA 2120i with Single Aspirate Autosampler see related information
Date Initiated by Firm March 05, 2021
Create Date April 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1390-2021
Recall Event ID 87488
510(K)Number K102644  K162977  
Product Classification Counter, differential cell - Product Code GKZ
Product ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer

Software Versions 6.10 and 6.11
Code Information Software Versions 6.10 and 6.11 UDI: 00630414581965
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
FDA Determined
Cause 2
Under Investigation by firm
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.
Quantity in Commerce 15 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS