Dimension® EXL™ 200 Integrated Chemistry System 10636929Recalls & reported problems

Summary

The FDA's MAUDE database contains 373 adverse event reports that list this exact device (DI 00630414593579), received between Jul 18, 2017 and Sep 29, 2026 — classified as 373 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (134 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 373 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Low Test Results

  The customer reported that they obtained two erroneously depressed Sodium (Na) results on a patient sample on a Dimension EXL 200 Integrated Chemistry System.The initial result was reported to the physician(s) and was questioned. The sample was repeated on the same system and the result obtained was higher than the initial result but was in the critical range. The repeat result was reported to the physician(s) and was questioned. The physician(s) asked to redraw the sample. A new sample was drawn from the same patient and processed on the same system. The result obtained was higher than the previous results, 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 Na results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928237 ↗
• MalfunctionSep 25, 2026Low Test Results

  The customer reported that they obtained an erroneously depressed Sodium (Na) result 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 on the same Dimension EXL 200 Integrated Chemistry System and higher result was obtained. The repeat result was reported to the physician(s) as correct result.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 50895615 ↗
• MalfunctionSep 11, 2026Low Test Results

  The customer reported that an erroneously depressed Sodium (Na) result was obtained on a Dimension EXL 200 Integrated Chemistry System. The sample was repeated on the original system. Additionally, a new sample was drawn from the same patient and processed on the original system. The redrawn sample result was higher than the initial result, 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 Sodium result.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728740 ↗
• MalfunctionMay 22, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED FOR A PATIENT ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PHYSICIAN QUESTIONED THE RESULT. THE RESULT WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257106 ↗
• MalfunctionMay 22, 2026Low Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED ON THE SAME DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) DUE TO THE DEPRESSED RESULT. A NEW SAMPLE WAS DRAWN AGAIN IN THE ER AND TESTED; THE RESULT OBTAINED WAS SIMILAR TO THE PREVIOUS REPEAT RESULT. BOTH REPEAT RESULTS WERE CONSISTENT AND CONSIDERED CORRECT. THE REDRAWN SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252674 ↗
• MalfunctionMay 15, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED SODIUM (NA) 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 SAME INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. 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 25184842 ↗
• MalfunctionMay 5, 2026Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT FOR TROUBLESHOOTING PURPOSES. THEN THE SAME SAMPLE WAS REPEATED ON NON-SIEMENS INSTRUMENT. THE REPEAT RESULT FROM NON-SIEMENS INSTRUMENT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED K RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078915 ↗
• MalfunctionApr 1, 2026Low Test Results

  A FALSELY LOW SODIUM TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE FROM A DIMENSION EXL 200 ANALYZER. THE INITIAL TEST RESULT WAS NOT RELEASED TO A PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON THE SAME AND AN ALTERNATE DIMENSION EXL 200 ANALYZER. THE TEST RESULT FROM THE ALTERNATE ANALYZER WAS HIGHER, 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 24755352 ↗
• MalfunctionMar 9, 2026Low Readings

  THE CUSTOMER REPORTED A FALSELY DEPRESSED N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT THE REPEAT RESULT WAS HIGHER 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543617 ↗
• MalfunctionFeb 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A DISCORDANT RESULT WAS OBTAINED FOR A GLUCOSE (GLUC) RESULT ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 ANALYZER. THE RESULT WAS FLAGGED WITH AN ABNORMAL REACTION AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. 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 ABNORMAL REACTION ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349635 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SAMPLE WAS INITIALLY TESTED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SAMPLE WAS REPEATED ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT AND CONSIDERED ERRONEOUS. THE REPEAT, ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE INITIAL 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 TAC RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247596 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS WERE LOWER 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246993 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULTS WERE LOWER 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246766 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS WERE LOWER 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246549 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED 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 AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULTS. 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246441 ↗
• MalfunctionFeb 3, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED 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 AN ALTERNATE INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULTS. 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 24246327 ↗
• MalfunctionFeb 2, 2026Low Readings

  THE CUSTOMER REPORTED A FALSELY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT WAS HIGHER 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 DEPRESSED TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235197 ↗
• MalfunctionFeb 2, 2026Low Readings

  THE CUSTOMER REPORTED A FALSELY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULT WAS HIGHER 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 DEPRESSED TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235193 ↗
• MalfunctionFeb 2, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE 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 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234307 ↗
• MalfunctionFeb 2, 2026Low Readings

  THE CUSTOMER REPORTED A FALSELY DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SAMPLE WAS INITIALLY TESTED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SAMPLE WAS REPEATED ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULT WAS LOWER THAN THE INITIAL RESULT AND CONSIDERED ERRONEOUS. THE REPEAT, ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE INITIAL 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234043 ↗
• MalfunctionFeb 2, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233601 ↗
• MalfunctionJan 30, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223100 ↗
• MalfunctionJan 30, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223065 ↗
• MalfunctionJan 30, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222906 ↗
• MalfunctionJan 30, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON 1 PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE 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 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 TAC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222586 ↗