Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500… — Class II medical device recall Z-1703-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-04-05, distributed nationwide. Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after
| Recall number | Z-1703-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2017-03-03 |
| Classified | 2017-03-30 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, MY, NL, NO, NZ, PT, QA, SA, SI, SK |
| Quantity | 2,733 systems |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.