DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63522Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14987666545089), received between Sep 5, 2025 and May 14, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

4 FDA recall records name this device's identifier, 4 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 2, 2026Open, Classified

   Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and [email protected] in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.

   Z-0083-2027 · Root cause: Software design · FDA record ↗

2. Jul 15, 2026Open, Classified

   a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.

   Z-2973-2026 · Root cause: Software design (manufacturing process) · FDA record ↗

3. Sep 19, 2025Open, Classified

   Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

   Z-0215-2026 · Root cause: Software design · FDA record ↗

4. Aug 4, 2025Open, Classified

   On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

   Z-0032-2026 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS FOR ION SELECTIVE ELECTRODE ON SODIUM, POTASSIUM AND CHLORIDE ON THEIR DXC 500I CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178441 ↗
• InjuryMar 13, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH LACTATE PATIENT RESULTS ON THEIR DXC 500I CHEMISTRY ANALYZER. THE CUSTOMER STATED THAT TWO (2) PATIENTS RECEIVED FLUID BOLUS TREATMENT BECAUSE OF THE ELEVATED RESULTS. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT PROVIDED THE RESULTS FOR THIS PATIENT. MDR-2 ADDRESSES A SECOND PATIENT WHO RECEIVED TREATMENT. MDR-1, ADDRESSES FIRST PATIENT (PATIENT 1), IS REFERENCED IN MDR 9612296-2026-00052.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599211 ↗
• InjuryFeb 4, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH LACTATE PATIENT RESULTS ON THEIR DXC 500I CHEMISTRY ANALYZER. THE CUSTOMER STATED THAT TWO (2) PATIENTS RECEIVED FLUID BOLUS TREATMENT BECAUSE OF THE ELEVATED RESULTS. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT PROVIDED RESULTS FOR THIS PATIENT. MDR-1: FOR FIRST PATIENT (PATIENT 1) IS REFERENCED IN MDR 9612296-2026-00052. MDR-2: FOR A SECOND PATIENT (PATIENT 2) IS REFERENCED IN A NEW MDR 9612296-2026-00110.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260135 ↗
• MalfunctionDec 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SODIUM PATIENT RESULTS GENERATED ON THEIR DXC500AU CLINICAL CHEMISTRY ANALYZER (P/N C63522 SN (B)(6)). THERE WAS NO REPORT OF INJURY, DEATH OR DELAYED/CHANGE IN TREATMENT OR DIAGNOSIS ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688669 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THERE WAS A DELAY IN RESULTS AND DIAGNOSIS AND TREATMENT FOR ONE (1) PATIENT INVOLVING THEIR DXC 500I CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THEY RECEIVED TROPONIN (HSTNI) AND TSH (THYROID STIMULATING HORMONE) PATIENT RESULTS 1-2 HOURS LATE AND B-TYPE NATRIURETIC PEPTIDE (BNP) RESULTS WERE DELAYED FOR 6 HOURS. THE CUSTOMER STATED THAT THE DELAY IN RESULTS WAS DUE TO NOT HAVING QUALITY CONTROL (QC) AND THEY COULD NOT REPORT PATIENT RESULTS. THE PATIENT HEART ATTACK DIAGNOSIS AND TREATMENT WERE DELAYED DUE TO DELAY IN RESULTS. AFTER OBTAINING RESULTS, AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, TROPONIN LEVELS TESTING WAS ORDERED AND PERFORMED WHICH CONFIRMED ELEVATED RESULTS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS PROVIDED TREATMENT. THERE IS NO DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22978325 ↗