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 Siemens is investigating an issue which may cause...
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.
Quantity: US: 23 systems; Foreign: 141 systems
Why Was This Recalled?
Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
Where Was This Sold?
This product was distributed to 12 states: CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WY
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