Dimension Vista® Flex® reagent cartridge CO2 10445163Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00842768015625), received between Apr 27, 2018 and May 19, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K061238); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON A DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM. THE ERRONEOUSLY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S), AS THE CUSTOMER IDENTIFIED AND CORRECTED THEM BEFORE THE PHYSICIAN(S) BECAME AWARE, EVEN THOUGH THE RESULTS HAD BEEN ENTERED INTO THE LABORATORY INFORMATION SYSTEM (LIS). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM. THE REPROCESSED RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULTS. THE HIGHER REPROCESSED 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 ERRONEOUSLY DEPRESSED CARBON DIOXIDE (CO2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043144 ↗
• MalfunctionMar 1, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPROCESSED THE SAME SAMPLE ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM. THE REPROCESSED RESULT RECOVERED HIGHER THAN THE INITIAL DEPRESSED RESULT. 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 FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815385 ↗
• MalfunctionSep 1, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME INSTRUMENT ON THE SAME DATE AND LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED. CORRECTED REPORTS WERE ISSUED THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479845 ↗
• MalfunctionJun 4, 2020Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON ONE PATIENT'S SAMPLES ON THE DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DAY ON A NON-SIEMENS INSTRUMENT AND HIGHER RESULTS, REGARDED AS CORRECT, WERE OBTAINED. CORRECTED RESULTS WERE REPORTED FROM THE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121298 ↗
• MalfunctionJun 4, 2020Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON ONE PATIENT'S SAMPLES ON THE DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DAY ON A NON-SIEMENS INSTRUMENT AND HIGHER RESULTS, REGARDED AS CORRECT, WERE OBTAINED. CORRECTED RESULTS WERE REPORTED FROM THE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121289 ↗
• MalfunctionJun 4, 2020Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON ONE PATIENT'S SAMPLES ON THE DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DAY ON A NON-SIEMENS INSTRUMENT AND HIGHER RESULTS, REGARDED AS CORRECT, WERE OBTAINED. CORRECTED RESULTS WERE REPORTED FROM THE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121270 ↗
• MalfunctionJun 4, 2020Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON ONE PATIENT'S SAMPLES ON THE DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DAY ON A NON-SIEMENS INSTRUMENT AND HIGHER RESULTS, REGARDED AS CORRECT, WERE OBTAINED. CORRECTED RESULTS WERE REPORTED FROM THE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121264 ↗
• MalfunctionJun 4, 2020Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULTS WERE OBTAINED ON ONE PATIENT'S SAMPLES ON THE DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DAY ON A NON-SIEMENS INSTRUMENT AND HIGHER RESULTS, REGARDED AS CORRECT, WERE OBTAINED. CORRECTED RESULTS WERE REPORTED FROM THE NON-SIEMENS INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121253 ↗
• MalfunctionOct 25, 2019Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) PATIENT RESULT WAS OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED AT AN ALTERNATE FACILITY ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND THE ORIGINAL LOW RESULT WAS CONFIRMED. A NEW PATIENT SAMPLE WAS DRAWN AT AN ALTERNATE FACILITY AND PROCESSED ON THE SAME DAY AND REPROCESSED ON A LATER DATE ON A NON-SIEMENS BLOOD GAS ANALYZER METHODOLOGY AND HIGHER CORRECT RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241251 ↗
• MalfunctionOct 25, 2019Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) PATIENT RESULT WAS OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED AT AN ALTERNATE FACILITY ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND THE ORIGINAL LOW RESULT WAS CONFIRMED. A NEW PATIENT SAMPLE WAS DRAWN AT AN ALTERNATE FACILITY AND PROCESSED ON A LATER DATE ON A NON-SIEMENS BLOOD GAS ANALYZER METHODOLOGY AND A HIGHER CORRECT RESULT WAS OBTAINED AND REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241249 ↗
• MalfunctionSep 11, 2019Incorrect Measurement; Incorrect Measurement

  DISCORDANT CARBON DIOXIDE (CO2) PATIENT RESULTS WERE OBTAINED ON A GROSSLY LIPEMIC PATIENT SAMPLE WHEN PROCESSED ON A DIMENSION VISTA 500 SYSTEM. THE SAMPLE WAS CENTRIFUGED AGAIN AND REPROCESSED. THE ORIGINAL AND REPEAT RESULTS AFTER ADDITIONAL CENTRIFUGATION OF THE SAMPLE WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. A WHOLE BLOOD SAMPLE FROM THE SAME PATIENT WAS PROCESSED ON THE SAME DAY WITH AN ALTERNATE METHODOLOGY AND A CORRECTED CO2 RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT CO2 RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8992808 ↗
• MalfunctionFeb 27, 2019Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) PATIENT RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A NEW PATIENT SAMPLE WAS PROCESSED ON A NON-SIEMENS ALTERNATE METHODOLOGY AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374163 ↗
• MalfunctionFeb 27, 2019Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CARBON DIOXIDE (CO2) PATIENT RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A NEW PATIENT SAMPLE WAS PROCESSED ON A NON-SIEMENS ALTERNATE METHODOLOGY AND A HIGHER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8374162 ↗
• MalfunctionMay 3, 2018Mechanical Problem; Mechanical Problem

  DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) TEST RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON THE SAME DIMENSION VISTA 500 INSTRUMENT AND AN ALTERNATE DIMENSION VISTA 500 INSTRUMENT. THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). BOTH PATIENTS WERE REDRAWN AND TESTED FOR CARBON DIOXIDE (CO2) ON THE ALTERNATE DIMENSION VISTA 500. THE TEST RESULTS FOR THE REDRAWS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CARBON DIOXIDE (CO2) TEST RESULTS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7483746 ↗
• MalfunctionApr 27, 2018Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED CARBON DIOXIDE (CO2) RESULT WAS OBTAINED ON A PATIENT VENOUS SAMPLE ON TWO DIMENSION VISTA 1500 SYSTEMS. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. AN ARTERIAL BLOOD SAMPLE FROM THE SAME PATIENT WAS TESTED BY AN ALTERNATE NON-SIEMENS METHODOLOGY (BLOOD GAS ANALYZER) AND A HIGHER RESULT WAS OBTAINED. THE ORIGINAL VENOUS SAMPLE WAS REPEATED ON THE ALTERNATE METHODOLOGY AND THE HIGHER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CO2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469870 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061238. One submission often covers many models, so check the product and lot details in each record.

• Z-2741-2015 · Jul 15, 2015 · Terminated
  Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the