DxC AURecalls & reported problems across all models

We found 4 models of DxC AU by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 632 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2018 and Sep 30, 2026 — classified as 1 death, 66 injuries, 565 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (302 reports).

8 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DxC AU recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · 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) · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported DxC AU problems

DxC AU models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DxC AU B86444

  Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  1 death588 reports
• DxC AU C63520

  Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  8 recalls17 reports
• DxC AU C63519

  Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  6 recalls0 reports
• DxC AU B86446

  Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  27 reports

Recent DxC AU adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Insufficient Information

  MAUDE report 50952696 ↗
• MalfunctionSep 30, 2026Low Test Results

  The customer reported the generation of erroneously low Sodium (NA) patient results on their DxC 700 AU Clinical Chemistry Analyzer. There was no report of change to treatment, injury, or death associated with event. The customer did not provide demographics. Data was provided for three patient samples.

  Patient problems: Insufficient Information

  MAUDE report 50949330 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938366 ↗
• MalfunctionSep 23, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872158 ↗
• MalfunctionSep 10, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722874 ↗
• InjuryJun 23, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR GLUCOSE, ALBUMIN, AND MAGNESIUM ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE RELEASED OUTSIDE THE LABORATORY. THE CUSTOMER INDICATED A CHANGE IN PATIENT MANAGEMENT, WHERE THE PATIENT WAS STARTED ON MAGNESIUM MEDICATION, WHICH WAS THEN DISCONTINUED AFTER CORRECTED RESULTS WERE AMENDED. BECKMAN COULTER CONTACTED THE CUSTOMER FOR MORE DETAILS, BUT THEY DECLINED TO PROVIDE ADDITIONAL PATIENT INFORMATION. HOWEVER, THEY CONFIRMED THE PATIENT WAS NOT HARMED. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593517 ↗
• MalfunctionJun 23, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH PATIENT RESULTS FOR SODIUM(NA) AND BICARBONATE (CO2) WITH LOW ANION GAP ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593510 ↗
• MalfunctionJun 23, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW PATIENT RESULTS FOR GLUCOSE (GLU), SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) ANALYTES ON THEIR DXC700AU ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS, THE EXACT NUMBER OF PATIENT SAMPLES AFFECTED IS UNKNOWN. 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 25593509 ↗
• MalfunctionJun 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC THREE (3) PATIENT RESULTS FOR SODIUM (NA), AND CHLORIDE (CL) DUE TO NEGATIVE ANION GAP VALUES, ON THE DXC 700 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 DEMOGRAPHICS BUT PROVIDED THE RESULTS FOR ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522663 ↗
• MalfunctionJun 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS ON ION SELECTIVE ELECTRODE FOR SODIUM, POTASSIUM AND CHLORIDE DUE TO LOW ANION GAP VALUES, INVOLVING THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE RELEASED OUTSIDE THE LABORATORY. HOWEVER, THE CUSTOMER INDICATED 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 25479238 ↗
• MalfunctionJun 11, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR MAGNESIUM, PHOSPHORUS, GLUCOSE AND SODIUM ON THEIR DXC 700 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 25477146 ↗
• MalfunctionJun 8, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING FALSE LOW TOTAL BILIRUBIN (TBIL) PATIENT RESULT FOR ONE PATIENT, ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PART NUMBER (PN) B86444, SERIAL NUMBER (SN) (B)(6). THE CUSTOMER REPEATED THE SAMPLE AND OBTAINED A RESULT CONSIDERED CORRECT BY THE CUSTOMER. THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436085 ↗
• MalfunctionJun 8, 2026Imprecise or Erratic Results

  THE CUSTOMER REPORTED OBTAINING FALSE HIGH SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) PATIENT RESULTS GENERATED WITH LOW ANION GAP CALCULATION VALUES ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PART NUMBER (PN) B86444, SERIAL NUMBER (SN) (B)(6). THE CUSTOMER REPEATED THE SAMPLE AND OBTAINED A RESULT CONSIDERED CORRECT BY THE CUSTOMER. THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25433844 ↗
• MalfunctionJun 5, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR MULTIPLE CHEMISTRIES INCLUDING SODIUM, CHLORIDE, TOTAL PROTEIN, ASPARTATE AMINOTRANSFERASE, MAGNESIUM, BLOOD UREA NITROGEN, GLUCOSE AND PHOSPHORUS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE PATIENT SAMPLE WAS REPEATED ON A DIFFERENT AU ANALYZER 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 25416298 ↗
• MalfunctionJun 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC SODIUM PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THOSE ERRATIC RESULTS WERE NOT RELEASED 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 25399621 ↗

Other Beckman Coulter, Inc. products

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• UniCel DxH4 models · 74 reports · 2 recalls
• Access AccuTnI+32 models · 165 reports
• REMISOL Advance2 models · 0 reports · 2 recalls
• Access TSH (3rd IS)2 models · 7 reports · 1 recall