Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA 560 Hematology Systems Recalled by Siemens Healthcare Diagnostics, Inc. Due to Software anomaly; Siemens identified that software version 1.4.2133...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
Quantity: US: 8 systems; Foreign: 64 systems
Why Was This Recalled?
Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in t
Where Was This Sold?
Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of : Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report