Dimension® EXL™ with LM Integrated Chemistry System 10472176Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00842768030024), received between Feb 6, 2018 and Apr 10, 2026 — classified as 1 injury, 72 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (31 reports).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K130276); 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.

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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON 2 PATIENT SAMPLES ON A DIMENSION EXL WITH LM 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 HIGHER 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 24845226 ↗
• MalfunctionMar 23, 2026Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT WHILE PERFORMING TROUBLESHOOTING FOR A LEAK THAT WAS COMING FROM THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM, THE CUSTOMER ACCIDENTALLY RIPPED THE POSITIVE CABLE OFF THE REAGENT PROBE CLEANER PUMP. THE CUSTOMER RECEIVED AN ELECTRIC SHOCK WHEN TOUCHING THE CABLE, WHICH WAS HANGING LOOSE.

  Patient problems: Electric Shock

  MAUDE report 24661156 ↗
• MalfunctionAug 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCORDANT SODIUM (NA) AND POTASSIUM (K) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE PATIENT DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, SODIUM (NA) AND POTASSIUM (K) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700702 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE REPROCESSED RESULT RECOVERED LOWER AND WAS CONSIDERED CORRECT. THEN, THE SAMPLE WAS REPROCESSED ON AN ADVIA CENTAUR XPT ANALYZER AND ATELLICA IM ANALYZER, WHICH ALSO PRODUCED SIMILAR LOWER RESULTS AND WERE CONSIDERED CORRECT. THE REPROCESSED RESULT OF 1.45 MIU/ML WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22279890 ↗
• MalfunctionApr 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE ANY PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM (NA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908594 ↗
• MalfunctionSep 20, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT THREE PATIENT SAMPLES WERE PROCESSED ON THE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM, WHICH RESULTED IN TWO FALSELY DEPRESSED SODIUM (NA) RESULTS. THE CUSTOMER DID NOT PROVIDE THE POTASSIUM (K) RESULT FOR THE SAMPLE IDENTIFIED AS (B)(6). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM, WHICH RECOVERED HIGHER THAN ERRONEOUS RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT THEY INADVERTENTLY DELETED ALL RESULTS PRIOR TO 25-AUG-2024; HENCE, IT IS UNKNOWN IF ADDITIONAL K RESULTS WERE ALSO IMPACTED. 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 20270981 ↗
• InjuryJul 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER CONTACTED SIEMENS AND REPORTED THAT ONE FALSELY DEPRESSED TROPONIN (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE TESTED ON A DIMENSION EXL ANALYZER. THE RESULT WAS RELEASED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME ANALYZER AND THE REPEAT RESULT WAS HIGHER AND RELEASED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832256 ↗
• MalfunctionJul 22, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL WITH LM INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL WITH LM INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT, WAS WITHIN THE CLINICAL PICTURE AND MATCHED THE PATIENT¿S HISTORY. THE REPEAT RESULT WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799761 ↗
• MalfunctionFeb 12, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL WITH LM INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT 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 DEPRESSED CRE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686951 ↗
• MalfunctionFeb 12, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL WITH LM INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED 2 TIMES ON THE SAME INSTRUMENT. THE REPEAT RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CRE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686863 ↗
• MalfunctionFeb 12, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL WITH LM INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT 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 DEPRESSED CRE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686747 ↗
• MalfunctionFeb 12, 2024Low Test Results; Low Test Results

  A FALSELY DEPRESSED CREATININE (CRE2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL WITH LM INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT 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 DEPRESSED CRE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686721 ↗
• MalfunctionDec 7, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (TNI) PATIENT RESULT WAS OBTAINED ON A DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, AND THE RESULT WAS QUESTIONED. ADDITIONALLY, A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE SAME DIMENSION EXL WITH LM SYSTEM. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282868 ↗
• MalfunctionDec 5, 2023Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED SODIUM (NA) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON A DIMENSION EXL SYSTEM. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION EXL SYSTEM, AND THE RESULT WAS HIGHER. THE HIGHER RESULT WAS CONSIDERED AS CORRECT RESULT BY THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PLACED ON FLUID RESTRICTIONS DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED SODIUM (NA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265393 ↗
• MalfunctionOct 18, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT A SAMPLE WAS DISPENSED INTO AN INCORRECT ALIQUOT POSITION ON THE DIMENSION EXL WITH LM INSTRUMENT, WHICH CAUSED A DELAY IN TESTING THE PATIENT SAMPLE AS THE SAMPLE NEEDED TO BE REPEATED. THE INSTRUMENT TRIGGERED THE FOLLOWING ERROR CODES: ¿SAMPLE ARM CANNOT DETECT SAMPLE¿ AND ¿ERROR CHECK LEVEL¿. THEN, THE INSTRUMENT CANCELLED THE ALIQUOT POSITION AND ALIQUOTED THE SAMPLE CORRECTLY IN A NEW ALIQUOT WELL. THE SAMPLE WAS TESTED, AND CORRECT PATIENT RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961445 ↗
• MalfunctionOct 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED SODIUM (NA) RESULT FOR THE PATIENT SAMPLE ID (B)(6) ON THE DIMENSION EXL SYSTEM WITH SERIAL NUMBER (B)(6) AND DID NOT REPORT THE RESULT TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE AND AN ALTERNATE DIMENSION SYSTEM TO PERFORM REPEAT TESTING AND NOTED THAT THE REPEAT RESULT WAS IN THE NORMAL RANGE AND CONSIDERED CORRECT. 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 17876770 ↗
• MalfunctionOct 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED SODIUM (NA) RESULT FOR THE PATIENT SAMPLE ID (B)(6) ON THE DIMENSION EXL SYSTEM WITH SERIAL NUMBER (B)(6) AND DID NOT REPORT THE RESULT TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE AND AN ALTERNATE DIMENSION SYSTEM TO PERFORM REPEAT TESTING AND NOTED THAT THE REPEAT RESULT WAS IN THE NORMAL RANGE AND CONSIDERED CORRECT. 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 17876090 ↗
• MalfunctionJul 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT SMOKE AND AN ELECTRICAL AND/OR PLASTIC BURNING ODOR EMITTED FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS) LOAD INPUT CABLE CONNECTION, WHICH WAS CONNECTED TO THE DIMENSION EXL WITH LM INSTRUMENT. THE INSTRUMENT SWITCHED OFF AND THERE WAS NO POWER TO THE MAIN PRINTED CIRCUIT BOARD. THE CUSTOMER REMOVED THE UPS POWER CORDS FROM BOTH THE OUTPUT AND INPUT AND TURNED THE UPS OFF. SIEMENS REQUESTED FOR THE CUSTOMER TO UNPLUG THE INSTRUMENT FROM THE WALL OUTLET; HOWEVER, THE CUSTOMER WAS UNABLE TO IDENTIFY THE CORD FOR THE DIMENSION EXL WITH LM. THE CUSTOMER POWERED OFF THE REAGENT MANAGEMENT SYSTEM (RMS). THERE WAS NO IMPACT TO PATIENT TESTING AS THE CUSTOMER WAS ABLE TO PROCESS PATIENT SAMPLES ON AN ALTERNATE INSTRUMENT. 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 17314925 ↗
• MalfunctionMay 30, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED ALBUMIN (ALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL INSTRUMENT. THE REPEAT RESULT RECOVERED HIGHER THAN THE ERRONEOUS RESULT AND MATCHED THE PATIENT'S PREVIOUS HISTORY. 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 ALB RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022891 ↗
• MalfunctionMay 3, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED ENZYMATIC CREATININE (EZCR) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL WITH LM SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE PATIENT WAS SENT TO ANOTHER FACILITY, WHERE A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE SYSTEM. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED. ADDITIONALLY, THE ORIGINAL SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM AT THE CUSTOMER SITE, AND A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT WAS TRANSFERRED TO AN ALTERNATE FACILITY DUE TO THE FALSELY ELEVATED EZCR RESULT. THERE ARE NO KNOWN REPORTS OF UNNECESSARY TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED EZCR RESULT OR PATIENT TRANSFER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859155 ↗
• MalfunctionDec 20, 2022Leak/Splash; Leak/Splash

  WHILE EMPTYING A CUVETTE WASTE BIN ON THE DIMENSION EXL WITH LM INSTRUMENT, A MEDICAL LABORATORY TECHNOLOGIST OBSERVED A LOOP OF USED CUVETTES HANGING OVER THE SIDE OF THE CUVETTE WASTE BIN. THE TECHNOLOGIST INDICATED WHEN SHE FLIPPED THE LOOP OF CUVETTES INTO THE BIN, A FEW DROPS OF LIQUID WASTE ALLEGEDLY SPLASHED ONTO HER FACE. SUBSEQUENTLY, SHE FELT A STINGING SENSATION IN ONE EYE. THE TECHNOLOGIST RINSED HER EYE WITH EYE WASH AND UNDERWENT A POST-EXPOSURE PROTOCOL AS PER THE LABORATORY'S STANDARD OPERATING PROCEDURE (SOP). NO FURTHER MEDICAL ATTENTION WAS REQUIRED. SHE WAS WEARING CORRECTIVE PRESCRIPTION LENSES AT THE TIME OF THE INCIDENT. THERE ARE NO KNOWN REPORTS OF ADVERSE PATIENT HEALTH CONSEQUENCES DUE TO THE EVENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.

  Patient problems: Eye Pain

  MAUDE report 16018495 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SIX (6) IMPRECISE MICROALBUMIN (MALB) PATIENT SAMPLE RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE IMPRECISE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE SIEMENS SYSTEM (ATELLICA) AT ANOTHER LABORATORY ON THE SAME DATE. THE RESULT FROM THE ALTERNATE SIEMENS SYSTEM (ATELLICA) WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE MICROALBUMIN (MALB) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949203 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SIX IMPRECISE MICROALBUMIN (MALB) PATIENT SAMPLE RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE IMPRECISE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE SIEMENS SYSTEM (ATELLICA) AT ANOTHER LABORATORY ON THE SAME DATE. THE RESULT FROM THE ALTERNATE SIEMENS SYSTEM (ATELLICA) WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE MICROALBUMIN (MALB) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949192 ↗
• MalfunctionNov 23, 2022Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED POTASSIUM (K) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION EXL WITH LM SYSTEM. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED 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 POTASSIUM (K) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851447 ↗
• MalfunctionSep 9, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED CALCIUM (CA) RESULT, FLAGGED WITH BELOW ASSAY RANGE, WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT, RECOVERING HIGHER. 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 CA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130276. One submission often covers many models, so check the product and lot details in each record.

• Z-0459-2016 · Nov 10, 2015 · Terminated
  Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The
• Z-0458-2016 · Nov 10, 2015 · Terminated
  Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension clinical chemistry system. The RMS
• Z-1615-2015 · Apr 2, 2015 · Terminated
  Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimen
• Z-2553-2014 · Jul 16, 2014 · Terminated
  Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929
• Z-2133-2014 · May 27, 2014 · Terminated
  Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.