Dimension® EXL™ 200 Integrated Chemistry System 10636928Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00842768037214), received between Sep 11, 2017 and Feb 11, 2026 — classified as 1 injury, 142 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (65 reports).

1 FDA recall record name this device's identifier.

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. Sep 28, 2018Class IITerminated

   Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock

   Z-0409-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Low Readings

  THE CUSTOMER REPORTED MULTIPLE FALSELY DEPRESSED TOTAL BILIRUBIN (TBI) RESULTS WERE OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE FOURTH 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315151 ↗
• MalfunctionFeb 11, 2026Low Readings

  THE CUSTOMER REPORTED A FALSELY DEPRESSED TOTAL BILIRUBIN (TBI) RESULT WAS OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). 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 24315071 ↗
• MalfunctionJul 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT, AND WAS CONSIDERED CORRECT AS, IT MATCHED THE PATIENT'S HISTORICAL PROFILE. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED NA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518450 ↗
• MalfunctionJul 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ORIGINAL INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE INITIAL RESULT AND WERE CONSIDERED CORRECT AS THEY MATCHED THE PATIENT'S HISTORICAL PROFILE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED NA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517846 ↗
• MalfunctionMay 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED CARDIAC TROPONIN I (CTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS OBTAINED WERE LOWER THAN THE INITIAL RESULT AND WERE CONSIDERED CORRECT. THE REPEAT RESULT OF 0.0073 NG/ML WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CTNI RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060246 ↗
• MalfunctionFeb 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT SODIUM AND POTASSIUM TESTING PERFORMED ON THE DIMENSION EXL 200 ANALYZER PRODUCED FALSELY DEPRESSED RESULTS ON TWO PATIENTS (SAMPLE IDS (B)(6)). THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING FOR SAMPLE ID (B)(6) AND NOTED THAT THE RESULTS REMAINED LOW; THEREFORE, THEY PERFORMED GASOMETER TESTING AND STATED THAT THE RESULTS WERE HIGHER, WITHIN NORMAL LIMITS, CONSIDERED CORRECT, AND REPORTED THE RESULTS TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING FOR SAMPLE ID (B)(6) ON THE DIMENSION EXL 200 ANALYZER AND NOTED THAT THE RESULTS REMAINED LOW. THE CUSTOMER PERFORMED TROUBLESHOOTING, VERIFIED QUALITY CONTROL (QC) RESULTS WERE ACCEPTABLE, PERFORMED REPEAT TESTING ON THE SAMPLE ID (B)(6), AND STATED THE RESULTS WERE HIGHER COMPARED TO THE INITIAL RESULTS, CONSIDERED CORRECT, AND WERE REPORTED TO THE PHYSICIAN(S). 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 21433502 ↗
• MalfunctionDec 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT SMOKE WAS EMITTED FROM THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE CUSTOMER POWERED OFF THE INSTRUMENT AND STORED THE PENDING SAMPLES IN A REFRIGERATOR AND PROCESSED THE SAMPLES ON THE FOLLOWING DAY. THERE ARE NO KNOWN REPORTS OF INJURY OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895961 ↗
• MalfunctionNov 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). AS PER THE LABORATORY¿S SETUP, SINCE THE INITIAL RESULT RECOVERED ABOVE 20 NG/ML, THE SAMPLE WAS MANUALLY DILUTED AND REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED LOWER. THE NEAT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND A RESULT OF 19.58 NG/ML WAS OBTAINED. THE RESULT OF 17.17 NG/ML 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 TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695984 ↗
• MalfunctionNov 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WAS PROCESSED FOR TACROLIMUS (TAC) ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM AND A RESULT OF 17.33 NG/ML WAS OBTAINED. THEN, THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE REPEAT RESULT RECOVERED FALSELY ELEVATED. THE FALSELY ELEVATED TAC RESULT WAS REPORTED TO THE PHYSICIAN(S). AS PER THE LABORATORY¿S SETUP, SINCE THE REPEAT RESULT RECOVERED ABOVE 20 NG/ML, THE SAMPLE WAS MANUALLY DILUTED AND REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED LOWER. THE NEAT SAMPLE WAS REPEATED AGAIN ON THE SAME INSTRUMENT AND A RESULT OF 14.24 NG/ML WAS OBTAINED. THE RESULT OF 14.24 NG/ML 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 TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694439 ↗
• MalfunctionOct 25, 2024High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUS SODIUM (NA) RESULTS ON TWO (2) PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. FOR SAMPLE IDENTIFIER (B)(6), THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. FOR SAMPLE IDENTIFIER (B)(6), THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SERUM SAMPLES FROM THE OTHER TUBES COLLECTED ALONGSIDE THE INITIALLY PROCESSED PLASMA SAMPLES, AS WELL AS THE INITIAL PLASMA SAMPLES FROM THE ORIGINAL TUBES, WERE REPROCESSED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. FOR SAMPLE IDENTIFIER (B)(6), HIGHER REPROCESSED RESULTS WERE OBTAINED ON BOTH SERUM AND PLASMA SAMPLES AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED USING THE SERUM SAMPLE RESULT. FOR SAMPLE IDENTIFIER (B)(6), HIGHER REPROCESSED RESULTS WERE OBTAINED ON A SERUM SAMPLE THAT WERE CONSIDERED ERRONEOUSLY ELEVATED AND NOT REPORTED TO THE PHYSICIAN(S). ALSO, A HIGHER REPROCESSED RESULT WAS OBTAINED ON A PLASMA SAMPLE COMPARED TO THE INITIAL RESULT, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531177 ↗
• MalfunctionOct 24, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED VALPROIC ACID (VALP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ELEVEN TIMES ON AN ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE FIRST FOUR REPEAT RESULTS WERE SIMILARLY DEPRESSED AND WERE CONSIDERED ERRONEOUS. THE REMAINING SEVEN REPEAT RESULTS RECOVERED HIGHER THAN THE INITIAL AND FIRST FOUR REPEAT RESULTS. THE SEVEN REPEAT RESULTS WERE CONSIDERED CORRECT AND THE REPEAT RESULT OF "60.15 UG/ML" WAS REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED VALP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520884 ↗
• MalfunctionOct 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT DIMENSION EXL 200 ENZYMATIC CREATININE DISCORDANT RESULTS WERE OBTAINED FOR ELEVEN PATIENTS, AND THAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAME SAMPLES ON AN ALTERNATE DIMENSION EXL ANALYZER AND NOTED THAT THE REPEAT RESULTS WERE CONSIDERED CORRECT. THE CUSTOMER ISSUED CORRECTED REPORTS. 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 20446035 ↗
• MalfunctionOct 3, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED TACROLIMUS (TAC) RESULT WAS GENERATED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO PHYSICIAN. THE SAMPLE WAS REPEATED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM TWICE AND BOTH RESULTS RECOVERED HIGHER. THE REPEAT RESULTS CORRELATED WITH THE PATIENT¿S PREVIOUS RESULTS AND TREATMENT STATUS. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN, AS THE CORRECT RESULTS. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357972 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM TWICE. THE REPEAT RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULT AND CORRELATED TO THE PATIENT¿S CLINICAL PICTURE. THE REPEAT RESULT OF 5.5 NG/ML 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 TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353439 ↗
• MalfunctionJul 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON THE DIMENSION EXL 200 INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED SEVERAL TIMES ON THE ORIGINAL INSTRUMENT; WITH THE EXCEPTION OF THE SECOND REPEAT RESULT FOR THE SAMPLE IDENTIFIED AS 00620112704, THE REPEAT RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULTS. FOR THE SAMPLE IDENTIFIED AS 00620112704, THE SECOND REPEAT RESULT RECOVERED LOWER AND WAS CONSIDERED ERRONEOUS. THE HIGHER REPEAT RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754194 ↗
• MalfunctionDec 1, 2023Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED TROPONIN PATIENT RESULT WAS GENERATED FOR ONE PATIENT ON A DIMENSION EXL 200 INSTRUMENT. THE INITIAL RESULT WAS NOT SENT TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT TWICE. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248651 ↗
• MalfunctionOct 20, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBI) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. ON (B)(6) 2023 THE SAME SAMPLE WAS REPROCESSED IN TRIPLICATE ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM FOR TROUBLESHOOTING PURPOSES ONLY. ON (B)(6) 2023 AND (B)(6) 2023 ADDITIONAL PATIENT SAMPLES FROM THE SAME PATIENT WERE DRAWN AND PROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE HIGHER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION AND ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TOTAL BILIRUBIN (TBI) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974538 ↗
• MalfunctionSep 29, 2023Low Test Results; Low Test Results

  TWO (2) DISCORDANT FALSELY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE DURING THE REPEAT TESTING ON A DIMENSION EXL 200 SYSTEM. ONE OF THE FALSELY DEPRESSED RESULTS WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 SYSTEM. HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND MATCHED THE PRIOR TNIH RESULT OBTAINED DURING THE INITIAL TESTING. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION AND ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842141 ↗
• MalfunctionSep 6, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692006 ↗
• MalfunctionAug 30, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE HIGHER RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652324 ↗
• MalfunctionAug 23, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED ENZYMATIC CREATININE (EZCR) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS EXPECTED BY THE DOCTOR AND WAS REPORTED AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED EZCR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604390 ↗
• MalfunctionAug 2, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CREATININE (CRE2) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL 200 SYSTEM. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION EXL 200 SYSTEM. A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION AND ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CREATININE (CRE2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446995 ↗
• MalfunctionJul 21, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED VALPROIC ACID (VALP) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM IN TRIPLICATE AND THE RESULTS OBTAINED WERE CONSIDERED CORRECT. THE SAME SAMPLE WAS ALSO REPROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM. THE REPROCESSED RESULT FROM AN ALTERNATE NON-SIEMENS SYSTEM WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED VALPROIC ACID (VALP) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372113 ↗
• MalfunctionMar 15, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED ENZYMATIC CREATININE (EZCR) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM AND A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED EZCR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547830 ↗
• MalfunctionMar 10, 2023Low Test Results; Low Test Results

  THREE (3) DISCORDANT FALSELY DEPRESSED TOTAL BILIRUBIN (TBI) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM. THE FALSELY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION® EXL¿ 200 INTEGRATED CHEMISTRY SYSTEM AND HIGHER RESULTS WERE OBTAINED. THE HIGHER RESULTS WERE REPORTED TO THE PHYSICIAN(S) ON CORRECTED REPORTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TBI RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524898 ↗