Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1404-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

Product Classification:

Class II

Date Initiated: March 5, 2021

Date Posted: April 21, 2021

Recall Number: Z-1404-2021

Event ID: 87488

Reason for Recall:

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Status: Ongoing

Product Quantity: 572 units

Code Information:

Software Versions 6.10 and 6.11

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.

Voluntary or Mandated:

Voluntary: Firm initiated