Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Recalled by Siemens Healthcare Diagnostics, Inc. Due to Siemens Healthcare Diagnostics has confirmed that in isolated...
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
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
Quantity: 2733 systems
Why Was This Recalled?
Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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