DxC AU C63520Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 14987666545065), received between Nov 12, 2024 and Apr 10, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (10 reports).

8 FDA recall records name this device's identifier, 8 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 500 AU 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-0084-2027 · 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-2974-2026 · Root cause: Software design (manufacturing process) · FDA record ↗

3. Mar 20, 2025Open, Classified

   Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.

   Z-1784-2025 · Root cause: Software design · FDA record ↗

4. Mar 17, 2025Open, Classified

   The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

   Z-1672-2025 · Root cause: Under Investigation by firm · FDA record ↗

5. Feb 26, 2025Open, Classified

   Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.

   Z-1517-2025 · Root cause: Software design · FDA record ↗

6. Jan 10, 2025Open, Classified

   Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

   Z-1233-2025 · Root cause: Software change control · FDA record ↗

7. Jul 10, 2024Open, Classified

   Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.

   Z-2691-2024 · Root cause: Software design · FDA record ↗

8. Jun 5, 2024Open, Classified

   There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.

   Z-2455-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING THREE (3) QUESTIONABLE PATIENT RESULTS FOR COMPLETE METABOLIC PANEL (CMP) ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WHICH INCLUDE SODIUM (NA), POTASSIUM, CHLORIDE (CL) AND CARBON DIOXIDE (CO2) WITH LOW ANION GAP (AGAP) INVOLVING THE DXC 500 AU CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844233 ↗
• MalfunctionFeb 18, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CALCIUM (CALC) AND BLOOD UREA NITROGEN (BUN PATIENT RESULTS ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377529 ↗
• MalfunctionFeb 9, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR SODIUM (NA) ANALYTE ON THEIR DXC500AU ANALYZER, PART NUMBER C63520, SERIAL NUMBER (B)(6). THE CUSTOMER CONFIRMED ALL AFFECTED SAMPLES WERE RERUN ON ANOTHER ANALYZER; NO ERRONEOUS RESULTS WERE RELEASED. THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA AND/OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293126 ↗
• MalfunctionDec 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS AND QUALITY CONTROL ON ION SELECTIVE ELECTRODE (ISE) INCLUDING SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. ONE PATIENT HAD RESULTS RELEASED OUTSIDE THE LABORATORY. HOWEVER, THE CUSTOMER REPEATED ALL SAMPLES AND AMENDED THE RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. PROVIDED RESULTS FOR ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917895 ↗
• MalfunctionDec 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW SODIUM PATIENT RESULTS AND QUALITY CONTROL FAILING ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. 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 23881084 ↗
• MalfunctionDec 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW ION-SELECTIVE ELECTROLYTES (ISE) PATIENT RESULTS, INCLUDING SODIUM (NA), CHLORIDE (CL) AND POTASSIUM (K), ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846191 ↗
• InjuryDec 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ONE PATIENT HAD LOW SODIUM RESULTS ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THE SAMPLE WAS RE-ANALYZED WITH NORMAL RESULT. DUE TO LOW SODIUM RESULT WAS RELEASED OUTSIDE THE LABORATORY, THE PATIENT RECEIVED TREATMENT WITH 3% SODIUM THROUGH IV FOR 10 MINUTES. THE CUSTOMER INDICATED THE PATIENT WAS NOT HARMED, AND NO DEATH WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT SHARED THE RESULTS FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844218 ↗
• MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC ION SELECTIVE ELECTRODE (ISE) RESULTS, INCLUDING SODIUM (NA), AND CHLORIDE (CL), ON PATIENT SAMPLES RUN ON THE DXC 500 AU CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS AND DATA OF THE ERRONEOUS RESULTS HAVE NOT BEEN PROVIDED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707046 ↗
• MalfunctionNov 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING TWO (2) FALSE ERRATIC ION SELECTIVE ELECTRODE (ISE) PATIENT RESULTS FOR SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) INVOLVING THE DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPORTED ONE (1) PATIENT RESULTS OUT OF THE LABORATORY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) FOR REDRAW AND REPEAT TESTING. THE PATIENT SAMPLE WAS REPEATED ON SAME ANALYZER AND BACK OBTAINING RESULTS WHICH MATCHED THE REDRAW SAMPLE RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648462 ↗
• MalfunctionNov 19, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE DXC 500 AU CLINICAL CHEMISTRY ANALYZER GENERATED FALSE HIGH CEREBRAL SPINAL FLUID (CSF) GLUCOSE RESULTS WITH %, F, AND HH FLAGS ON SURVEY PATIENT SAMPLES AND TEST SAMPLES USED FOR COMPARISON. THE CUSTOMER CONFIRMED THAT THE SAMPLES IN QUESTION GENERATING THE %, F, AND HH FLAGS WERE RELATED TO SURVEY SAMPLES WHICH WERE NOT USED FOR DIAGNOSIS. THERE WAS NO DELAY IN RESULTS OR SAMPLE PROCESSING AS THE CUSTOMER INDICATED THEY HAD A CONTINGENCY PLAN IN PLACE. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY OR DEATH ASSOCIATED TO THIS EVENT. PER DXC 500 AU CHEMISTRY ANALYZER INSTRUCTIONS FOR USE (IFU) GUIDE C24569AB, CHAPTER 11, PAGE 11-8 TO 11-9. FLAG ¿HH¿: THE RESULT IS GREATER THAN THE CONFIGURED CRITICALLY HIGH THRESHOLD. FLAG ¿F¿: RESULT IS HIGHER THAN THE ANALYTICAL MEASURING RANGE. FLAG %: CLOT DETECTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599090 ↗
• MalfunctionNov 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED LOW ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WHICH INCLUDES NA (SODIUM), K (POTASSIUM) AND CL (CHLORIDE) ON THEIR DXC500AU CLINICAL CHEMISTRY ANALYZER (PN C63520, SN (B)(6). THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA AND/OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528496 ↗
• InjuryJul 29, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW SODIUM (NA) PATIENT RESULTS ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPORTED THAT ONE PATIENT WAS HOSPITALIZED DUE TO THE LOW SODIUM RESULTS. THE CUSTOMER RECEIVED TREATMENT. NO FURTHER HARM TO THE PATIENT WAS REPORTED. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED DATA FOR SIXTY-FIVE (65) PATIENT SAMPLES; HOWEVER, IT IS UNKNOWN WHICH RESULTED IN THE HOSPITALIZATION.

  Patient problems: Hyponatremia

  MAUDE report 22650012 ↗
• MalfunctionJul 17, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW SODIUM PATIENT RESULTS ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534203 ↗
• MalfunctionMar 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A LEAK IN TUBING LINE 6 COMING OUT OF THE ISE BLOCK. AS A RESULT, PATIENT RESULTS RECOVERED LOW FOR SODIUM (NA) ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPEATED THE SAMPLE WITH NORMAL RESULTS. 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 21549155 ↗
• MalfunctionFeb 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE DXC 500 AU CLINICAL CHEMISTRY ANALYZER REPORTED ONE (1) PATIENT HAD MISMATCHING PATIENT RESULTS. THE PATIENT SAMPLE RAN ON (B)(6), POSITION 2 RAN TESTS UNDER THE WRONG PATIENT. THE PATIENT RESULTS FOR SODIUM (NA), CALCIUM (CALA), CHLORIDE (CL), BICARBONATE (CO2), CREATININE (CREA), GLUCOSE (GLU), POTASSIUM (K), AND MAGNESIUM (MG) OBTAINED WERE MISMATCHED, THE RESULTS DID NOT MATCH THE PATIENT TUBE (SAMPLE B). THE PATIENT RESULTS FOR PATIENT B WERE SENT TO ANOTHER BARCODED PATIENT (SAMPLE A) SAMPLE IDENTIFIER (ID): (B)(6) THAT HAD PREVIOUSLY BEEN PROGRAMMED ON SYSTEM AND NOT CLEARED. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE AFFECTED PATIENT SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND OBTAINED CORRECT RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360870 ↗
• MalfunctionNov 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ONE PATIENT HAD LOW SODIUM (NA) RESULTS AND LOW-QUALITY CONTROL ON TWO DIFFERENT DATES ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THE LOW RESULTS WERE REPORTED OUT THE LABORATORY BUT WERE QUESTIONED BY THE DOCTOR. THE CUSTOMER THEN SENT THE SAMPLE TO ANOTHER LABORATORY AND OBTAINED RESULTS MATCHED THE PATIENT¿S PROFILE. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED THE RESULTS FOR THIS PATIENT. MDR-1 IS FOR PATIENT RESULTS GENERATED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669298 ↗
• MalfunctionNov 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ONE PATIENT HAD LOW SODIUM (NA) RESULTS AND LOW-QUALITY CONTROL ON TWO DIFFERENT DATES ON THEIR DXC 500 AU CLINICAL CHEMISTRY ANALYZER. THE LOW RESULTS WERE REPORTED OUT THE LABORATORY BUT WERE QUESTIONED BY THE DOCTOR. THE CUSTOMER THEN SENT THE SAMPLE TO ANOTHER LABORATORY AND OBTAINED RESULTS MATCHED THE PATIENT¿S PROFILE. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED THE RESULTS FOR THIS PATIENT. MDR-2 IS FOR PATIENT RESULTS GENERATED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668982 ↗