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Open, Classified

ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

FDA Recall Z-1400-2021 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeGKZ
Date Initiated2021-03-05
Product Quantity969 units

Reason for Recall

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162977ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics · 2017-08-11K102644ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120ISiemens Healthcare Diagnostics · 2011-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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