Dimension Vista® 500 10284473Recalls & reported problems

Summary

The FDA's MAUDE database contains 524 adverse event reports that list this exact device (DI 00630414949581), received between Jun 14, 2017 and Sep 28, 2026 — classified as 3 injuries, 521 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (201 reports).

1 FDA recall record name this device's identifier.

31 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 15, 2021Class IITerminated

   Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

   Z-0331-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 524 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917239 ↗
• MalfunctionFeb 10, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THE FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL RESULTS AND WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303108 ↗
• MalfunctionJan 23, 2026High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ERRONEOUSLY ELEVATED CALCIUM (CA) RESULT WHEN PROCESSED ON DIMENSION VISTA 500 SYSTEM (S/N: (B)(6)). AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN BUT WAS NOT QUESTIONED. THE SAME SAMPLE WAS THEN RETESTED ON THE ORIGINAL SYSTEM AND OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND WAS ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160324 ↗
• MalfunctionJan 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A DISCORDANT GLUCOSE (GLU) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GLUCOSE (GLU) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943844 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME DIMENSION VISTA 500 SYSTEM. THE REPEAT 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 FALSELY ELEVATED K RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757612 ↗
• MalfunctionDec 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME DIMENSION VISTA 500 SYSTEM. THE REPEAT 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 FALSELY ELEVATED K RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756972 ↗
• MalfunctionNov 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED POTASSIUM (K) RESULTS ON THREE PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL SYSTEM AND LOWER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY, 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 K RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591190 ↗
• MalfunctionNov 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED POTASSIUM (K) RESULTS ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL SYSTEM AND LOWER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY, 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 K RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591188 ↗
• MalfunctionNov 14, 2025Low Test Results; Low Test Results

  A FALSELY DEPRESSED CALCIUM TEST RESULT WAS OBTAINED ON ONE PATIENT SAMPLE FROM A DIMENSION VISTA 500 ANALYZER. THE INITIAL TEST RESULT WAS NOT RELEASED. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA 500 ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND RELEASED TO A PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559719 ↗
• MalfunctionNov 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM. THE REPEAT RESULT RECOVERED HIGHER AND WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530196 ↗
• MalfunctionSep 10, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS NOT REPEATED FURTHER. PRIOR TO OBTAINING THE ERRONEOUS RESULT, THREE DIFFERENT SAMPLES WERE DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL SYSTEM. THE RESULTS FROM THESE PREVIOUSLY DRAWN SAMPLES WERE HIGHER THAN THE ERRONEOUS RESULT AND WERE REPORTED TO THE PHYSICIAN(S). AFTER THE ERRONEOUS RESULT WAS OBTAINED, TWO NEW SAMPLES WERE DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL SYSTEM. THE RESULTS FROM THE NEWLY DRAWN SAMPLES WERE ALSO HIGHER THAN THE ERRONEOUS RESULT AND WERE REPORTED TO THE PHYSICIAN(S). THE HIGHER RESULTS OBTAINED FROM THESE FIVE SAMPLES WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CRE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013385 ↗
• MalfunctionAug 1, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE IDENTIFIERS (B)(6) WERE REPEATED ON THE ORIGINAL INSTRUMENT AND WERE CONSIDERED ERRONEOUS. ALL THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT, EXCEPT THE SAMPLE IDENTIFIER 3865973, WHICH WAS REPEATED THRICE ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND WERE IN NORMAL RANGE. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). FOR SAMPLE IDENTIFIER (B)(6), A RESULT OF 28 MMOL/L WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CO2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684671 ↗
• MalfunctionJul 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM. OUT OF 4 SAMPLES, THE SAMPLE WITH IDENTIFIER (B)(6), THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM. THE REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL RESULTS AND WERE CONSISTENT WITH THE PATIENT'S PREVIOUS REPORTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CO2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574556 ↗
• MalfunctionJul 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE ORIGINAL AND ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULTS MATCHED THE PATIENT¿S CLINICAL CONDITION AND WERE CONSIDERED CORRECT. THE REPEAT RESULT FROM THE ORIGINAL INSTRUMENT 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 K RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528598 ↗
• MalfunctionJul 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM AND ON AN ALTERNATE DIMENSION VISTA SYSTEM. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND WITHIN THE NORMAL RANGE. THE REPEAT RESULTS OBTAINED FROM BOTH THE SYSTEM WERE CONSIDERED CORRECT AND THE REPEAT RESULT OBTAINED FROM THE ORIGINAL SYSTEM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED K RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517869 ↗
• MalfunctionJul 14, 2025Smoking; Smoking

  THE CUSTOMER REPORTED SMOKE AND A BURNING SMELL COMING FROM THE REAR LEFT-SIDE EXHAUST FAN OF A DIMENSION VISTA 500 INSTRUMENT. THE CUSTOMER STATED THAT THEY STOPPED THE INSTRUMENT; THE VISIBLE SMOKE CEASED, BUT THE BURNING SMELL PERSISTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO FIRE OR VISIBLE SPARKS OBSERVED, NO INJURIES OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492416 ↗
• MalfunctionJul 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED GLUCOSE (GLU) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE SAMPLE WAS DILUTED AND REPEATED ON THE SAME INSTRUMENT. THE ERRONEOUS DILUTED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT TWICE. THE REPEAT RESULTS OBTAINED ON THE ALTERNATE DIMENSION VISTA INSTRUMENT WERE LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT OF 87.68 MG/DL WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL INSTRUMENT AFTER SERVICE ACTIVITIES WERE PERFORMED ON THE INSTRUMENT. UPON REVIEWING THE INSTRUMENT DATA, SIEMENS DISCOVERED MULTIPLE REPEAT SODIUM (NA) AND POTASSIUM (K) RESULTS FOR SAMPLE ID (B)(6). THE CUSTOMER INDICATED THAT THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NO CORRECTED REPORTS WERE ISSUED. THE RESULTS FOR SAMPLE ID (B)(6) WERE INCLUDED IN THIS MDR IN AN ABUNDANCE OF CAUTION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472402 ↗
• MalfunctionJul 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE POINT OF CARE TESTING (POCT) INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPEAT 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 FALSELY ELEVATED CO2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384360 ↗
• MalfunctionJun 16, 2025Smoking; Smoking

  THE CUSTOMER REPORTED THAT THE EXTERNAL UNINTERRUPTIBLE POWER SUPPLY (UPS) FAILED, CAUSING A LOUD POPPING NOISE, AN ELECTRICAL SMELL, AND VISIBLE SMOKE ON THE DIMENSION VISTA 500 INSTRUMENT. THE CUSTOMER STATED THAT THERE WERE NO VISIBLE SPARKS OR FIRE ASSOCIATED WITH THE SMOKE. THERE WAS NO INJURY TO THE PATIENT, USER, OR OPERATOR DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22209358 ↗
• MalfunctionMay 23, 2025Low Test Results; Low Test Results

  THREE SAMPLES GAVE FALSELY DEPRESSED CARBON DIOXIDE (CO2) TEST RESULTS ON A DIMENSION VISTA 500. THE INITIAL TEST RESULTS WERE RELEASED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON THE SAME DIMENSION VISTA 500 AND CORRECTED REPORTS WERE RELEASED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE BEHAVIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078775 ↗
• MalfunctionMay 8, 2025Sparking; Sparking

  THE CUSTOMER REPORTEDLY OBSERVED A SPARK WHILE ATTEMPTING TO TROUBLESHOOT A DIMENSION VISTA 500 INSTRUMENT. THE INSTRUMENT MONITOR WAS UNRESPONSIVE DUE TO A DAMAGED POWER CABLE AND THE CUSTOMER TRIED TO TROUBLESHOOT THE DAMAGED CABLE AND OBSERVED A SPARK. THERE ARE NO KNOWN REPORTS OF VISIBLE FLAMES, SMOKE, INJURY, NOR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983780 ↗
• MalfunctionApr 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUS RESULTS FOR ASSAYS INCLUDING BUT NOT LIMITED TO CARBON DIOXIDE (CO2), CALCIUM (CA), AND GLUCOSE (GLU) ON AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE RESULTS WERE QUESTIONED. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT AND OBTAINED CORRECT RESULTS THAT MATCHED THE CLINICAL PICTURE OF THE AFFECTED PATIENTS. CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S) BASED ON REPEAT TESTING. THE CUSTOMER DECLINED TO PROVIDE SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932859 ↗
• MalfunctionApr 3, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). TRIGGERED BY A DELTA CHECK, THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT¿S PREVIOUS RESULT OF 5000 NG/L. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764016 ↗
• MalfunctionMar 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON TWENTY-SIX PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULTS. 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 FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661798 ↗
• MalfunctionNov 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUS CALCIUM (CA) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). FOR SAMPLE IDENTIFIER (B)(6) THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT AND WERE CONSIDERED ERRONEOUS. THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). FOR BOTH SAMPLE IDENTIFIERS, THE CUSTOMER DECLINED TO PROVIDE FURTHER INFORMATION ON THE PATIENT SAMPLE RESULTS DATA, INCLUDING THE CORRECT RESULTS OBTAINED. THEREFORE, THE CORRECT RESULTS REPORTED FOR THE TWO PATIENT SAMPLES ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795055 ↗

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-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-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-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-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
• Z-1454-2012 · Jan 16, 2012 · Terminated
  Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical proce

…and 16 more.