Dimension EXL with LM 10639337Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414593593), received between Jul 20, 2017 and Jul 11, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED SODIUM (NA) AND TOTAL BILIRUBIN (TBI) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL W/LM STM SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION SYSTEM AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976459 ↗
• MalfunctionJul 11, 2022Low Test Results; Low Test Results

  FIVE (5) DISCORDANT FALSELY DEPRESSED SODIUM (NA) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION EXL W/LM STM SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME DIMENSION SYSTEM AND HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976451 ↗
• MalfunctionJan 21, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DISCORDANT, FALSELY DEPRESSED, SODIUM (NA) RESULT ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME PATIENT SAMPLE TO PERFORM REPEAT TESTING ON AN ALTERNATE DIMENSION EXL INSTRUMENT. THE REPEAT RESULT WAS HIGHER, AND THE CUSTOMER NOTED THAT A CORRECTED REPORT WAS ISSUED. THERE ARE NO 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 11210868 ↗
• MalfunctionDec 15, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON TWO INSTRUMENTS RESULTING LOWER. THE CUSTOMER ONLY PROVIDED ONE REPEAT RESULT AND INDICATED THAT THE REPEAT RESULT OF 133 MMOL/L WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED NA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11014094 ↗
• MalfunctionAug 3, 2020Use of Device Problem; Use of Device Problem

  TWO SPARKS WERE OBSERVED BY THE OPERATOR OF A DIMENSION EXL WITH LOCI MODULE (LM) AND SAMPLE TRANSFER MODULE (STM) INSTRUMENT WHILE PERFORMING MAINTENANCE ON THE AIR MANIFOLD AND HEAT TORCH. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OBSERVED SPARKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10356319 ↗
• MalfunctionMar 13, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED INORGANIC PHOSPHOROUS (PHOS) PATIENT SAMPLE TEST RESULT WAS OBTAINED FROM A DIMENSION EXL WITH LOCI MODULE (LM) INSTRUMENT. THE INITIAL TEST RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT WHERE A LOWER TEST RESULT WAS OBTAINED. A CORRECTED TEST REPORT WAS ISSUED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED INORGANIC PHOSPHOROUS TEST RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9831755 ↗
• MalfunctionMay 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT, FALSELY LOW SODIUM (NA) RESULT AND CALCIUM RESULT WAS OBTAINED ON AN EMERGENCY ROOM (ER) PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE SAME PATIENT SAMPLE WAS REPEATED THE ON THE SAME DIMENSION EXL INSTRUMENT, RESULTING HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN ON APRIL 17TH, RUN TWICE ON AN ALTERNATE DIMENSION EXL INSTRUMENT, AND RESULTS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SODIUM AND CALCIUM RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604491 ↗
• MalfunctionJul 20, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED MICROALBUMIN (MALB) AND CREATININE URINE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. A FLAGGED BELOW ASSAY RANGE RESULT WAS REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ELEVATED URINE RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED MALB AND CRE2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6728775 ↗