Dimension® Flex® reagent cartridge EC02 10444972Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842768005374), received between Aug 14, 2018 and Mar 4, 2026 — classified as 7 malfunctions.

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

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULTS ON SIX (6) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. LOWER RESULTS WERE OBTAINED, 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 ECO2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508255 ↗
• MalfunctionSep 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED ON THE SAME SYSTEM. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS, AND WERE CONSIDERED CORRECT AS THE RESULTS WERE WITHIN PATIENT'S REFERENCE RANGE. THESE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED ECO2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035447 ↗
• MalfunctionJun 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO ERRONEOUSLY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULTS ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS AUTO REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM DUE TO HIGH PANIC FLAG ON THE INITIAL RESULT. THE AUTO REPROCESSED RESULT ALSO RECOVERED HIGHER WITH THE HIGH PANIC FLAG, WAS CONSIDERED ERRONEOUS, AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A LOWER RESULT WAS OBTAINED, 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 ENZYMATIC CARBONATE (ECO2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182495 ↗
• MalfunctionJan 6, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. A LOWER 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 ELEVATED ENZYMATIC CARBONATE (ECO2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080002 ↗
• MalfunctionJul 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED ENZYMATIC CARBONATE (ECO2) RESULTS ON TWO PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. THE REPROCESSED RESULTS RECOVERED HIGHER AND WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED ENZYMATIC CARBONATE (ECO2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730053 ↗
• MalfunctionJul 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULTS ON FOUR PATIENT SAMPLES ON A DIMENSION EXL WITH LM SYSTEM. THE ERRONEOUSLY ELEVATED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. THE REPROCESSED RESULTS RECOVERED LOWER AND 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 ELEVATED ENZYMATIC CARBONATE (ECO2) PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730021 ↗
• MalfunctionAug 14, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ENZYMATIC CARBONATE (ECO2) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON A DIMENSION EXL 200 INSTRUMENT USING THE ENZYMATIC CARBONATE FLEX REAGENT CARTRIDGE LOT EB9122. THE CUSTOMER REPLACED REAGENT ARM 1 PROBE AND REPEATED TWO SAMPLES, RESULTING IN TWO DISCORDANT, FALSELY ELEVATED ECO2 RESULTS. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). USING A NEW REAGENT FROM LOT EB9122, THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. THE 2ND REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ECO2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782805 ↗