Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA 1800 System Software V2.01. Performs assays for general and Recalled by Siemens Healthcare Diagnostics Due to Siemens Healthcare Diagnostics issued a Urgent Medical Device...
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 directly.
Affected Products
ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Quantity: 1366 units
Why Was This Recalled?
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report