FDA Devices Moderate Class II Ongoing

ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

Reported: April 21, 2021 Initiated: March 5, 2021 #Z-1396-2021

Product Description

Reason for Recall

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Details

Recalling Firm: Siemens Healthcare Diagnostics, Inc.
Units Affected: 132 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.
Location: Tarrytown, NY

Frequently Asked Questions

What product was recalled? ▼

ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 132 units.

Why was this product recalled? ▼

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1396-2021.