Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl- 10484429Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00842768030413), received between Oct 19, 2017 and Sep 3, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 reports).

32 other recalls cover devices cleared under the same FDA submission (K051087); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THIS SAMPLE COULD NOT BE REPROCESSED DUE TO QUANTITY NOT SUFFICIENT. A NEW SAMPLE WAS DRAWN AND PROCESSED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954560 ↗
• MalfunctionNov 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUS SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM, RESULTING IN NEGATIVE ANION GAPS. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM. THE REPROCESSED RESULTS FROM AN ALTERNATE DIMENSION VISTA 500 SYSTEM MATCHED THE PATIENT¿S CLINICAL PICTURE AND WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S), RESULTING IN POSITIVE ANION GAPS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619991 ↗
• MalfunctionOct 10, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT ELEVATED POTASSIUM (K) RESULTS ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. IT IS UNKNOWN IF THE SAMPLES WERE REPEATED AND CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DID NOT PROVIDE THE PATIENT DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED POTASSIUM (K) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415983 ↗
• MalfunctionOct 10, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED DISCORDANT ELEVATED SODIUM (NA) RESULTS ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. IT IS UNKNOWN IF THE SAMPLES WERE REPEATED AND CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DID NOT PROVIDE THE PATIENT DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415962 ↗
• MalfunctionOct 20, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM AND ON THE ORIGINAL DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. THE LOWER REPROCESSED RESULT FROM THE ALTERNATE DIMENSION VISTA 1500 SYSTEM WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974531 ↗
• MalfunctionSep 28, 2018Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SERUM SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THIS RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN LATER THE SAME DAY AND A HIGHER RESULT WAS OBTAINED IN AGREEMENT WITH EARLIER RESULTS AT AN ALTERNATE FACILITY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED POTASSIUM RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920014 ↗
• MalfunctionSep 28, 2018Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SERUM SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THIS RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A REDRAW SAMPLE WAS DRAWN LATER THE SAME DAY AND A HIGHER RESULT WAS OBTAINED IN AGREEMENT WITH EARLIER RESULTS AT AN ALTERNATE FACILITY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED POTASSIUM RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920012 ↗
• MalfunctionMar 14, 2018High Test Results; High Test Results

  DISCORDANT, IMPRECISE POTASSIUM (K) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, IMPRECISE POTASSIUM RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339706 ↗
• MalfunctionMar 14, 2018High Test Results; High Test Results

  A DISCORDANT, IMPRECISE POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, IMPRECISE POTASSIUM RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339703 ↗
• MalfunctionOct 19, 2017High Test Results; High Test Results

  A DISCORDANT HIGH POTASSIUM (K) RESULT WAS OBTAINED ON A PLASMA SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE PATIENT PLASMA RESULT WAS NOT REPORTED TO THE PHYSICIAN. A SERUM SAMPLE FROM THE SAME DRAW WAS RUN ON THE SAME DAY ON THE SAME DIMENSION VISTA INSTRUMENT AND A LOWER RESULT WAS OBTAINED AND IT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH PLASMA POTASSIUM (K) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6963378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051087. One submission often covers many models, so check the product and lot details in each record.

• Z-0331-2022 · Oct 15, 2021 · Terminated
  Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determi
• Z-0330-2022 · Oct 15, 2021 · Terminated
  Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determi
• Z-1014-2019 · Dec 12, 2018 · Terminated
  Dimension Vista 500, Analyzer, chemistry Model no. 10284473
• Z-0616-2019 · Oct 16, 2018 · Terminated
  Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral
• Z-1703-2017 · Mar 3, 2017 · Terminated
  Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemen
• Z-1886-2016 · Mar 24, 2016 · Terminated
  Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension
• Z-1885-2016 · Mar 24, 2016 · Terminated
  Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension V
• Z-1622-2016 · Feb 16, 2016 · Terminated
  Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of
• Z-2054-2015 · May 21, 2015 · Terminated
  Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
• Z-0838-2015 · Nov 5, 2014 · Terminated
  Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such a
• Z-0024-2015 · Aug 28, 2014 · Terminated
  Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista Syst
• Z-1733-2014 · Apr 14, 2014 · Terminated
  Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension V
• Z-0851-2014 · Oct 7, 2013 · Terminated
  User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dim
• Z-2088-2013 · Jun 19, 2013 · Terminated
  Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual an
• Z-0430-2014 · May 20, 2013 · Terminated
  Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a var

…and 17 more.