Dimension Vista® 1500 Intelligent Lab System 10459469Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414949536), received between Jan 21, 2019 and Mar 17, 2026 — classified as 9 malfunctions.

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

35 other recalls cover devices cleared under the same FDA submission (K051087, K143720); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED CALCIUM (CA) RESULTS ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 1500 SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM. THE REPEAT RESULTS RECOVERED LOWER, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614509 ↗
• MalfunctionMay 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MULTIPLE DISCORDANT SODIUM PATIENT RESULTS WERE OBTAINED ON A DIMENSION VISTA 1500 (SN: (B)(6)) INSTRUMENT. THE INITIAL SAMPLES WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. NEW SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 1500 INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER COULD NOT PROVIDE THE SPECIFIC, DISCORDANT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991954 ↗
• MalfunctionMar 13, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED 38 FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS FOR DIFFERENT PATIENTS ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLES TO PERFORM REPEAT TESTING ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM. THE REPEAT RESULTS WERE HIGHER AND REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16533277 ↗
• MalfunctionJun 27, 2022Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED LIPASE (LIPL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA® 1500 INTELLIGENT LAB SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION INSTRUMENT. THE REPROCESSED RESULT WAS HIGHER THAN THE DISCORDANT RESULT AND AGREED WITH THE PATIENT'S CLINICAL PICTURE. THE REPROCESSED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIPL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831080 ↗
• MalfunctionAug 18, 2021High Test Results; High Test Results

  A FLAGGED FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE TEST RESULT WAS OBTAINED FROM A DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL TEST RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA 1500 INSTRUMENT AND A LOWER, UNFLAGGED TEST RESULT WAS OBTAINED. THE REPEAT RESULT WAS NOT REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE LABORATORY STATED THE DIFFERENCE IN TEST RESULTS WAS CLINICALLY INSIGNIFICANT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338835 ↗
• MalfunctionNov 24, 2020Low Test Results; Low Test Results

  A FALSELY DEPRESSED SODIUM (NA) TEST RESULT WAS OBTAINED FROM A DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED THE NEXT DAY ON AN ALTERNATE VISTA 1500 INSTRUMENT. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) TEST RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10889959 ↗
• MalfunctionJul 10, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW CALCIUM (CA) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES AND DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON FOUR (4) PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED ON THE PATIENT SAMPLES. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CA AND CO2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777563 ↗
• MalfunctionJul 10, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW CALCIUM (CA) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES AND DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON FOUR (4) PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND HIGHER RESULTS WERE OBTAINED ON THE PATIENT SAMPLES. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CA AND CO2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777561 ↗
• MalfunctionJan 21, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) RESULT WAS OBTAINED ON AN INFANT PATIENT SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. A NEW SAMPLE DRAWN FROM THE SAME PATIENT WAS PROCESSED ON AN ALTERNATE DIMENSION VISTA AND A HIGHER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBIL) RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8263955 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051087, K143720. One submission often covers many models, so check the product and lot details in each record.

• 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-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-1015-2019 · Dec 12, 2018 · Terminated
  Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
• Z-1014-2019 · Dec 12, 2018 · Terminated
  Dimension Vista 500, Analyzer, chemistry Model no. 10284473
• Z-0617-2019 · Oct 16, 2018 · Terminated
  Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral
• 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-1672-2018 · Jan 2, 2018 · Terminated
  Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge
• 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

…and 20 more.