DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module C13252Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15099590742331), received between Apr 8, 2026 and Sep 23, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

3 FDA recall records name this device's identifier, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 · Recall details · FDA record ↗

2. Jul 15, 2026Class IIOpen, 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) · Recall details · FDA record ↗

3. Sep 19, 2025Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871504 ↗
• MalfunctionSep 23, 2026No Device Output

  On (b)(6) 2026, the customer reported that their DxC 500i Access 2 instrument (Part Number: C13252; Serial Number (b)(6)) was generating a timeout error and causing the instrument to remain in a busy state without processing a sample.The customer reported that one Troponin patient sample experienced a turnaround delay, however there was no report of any impact to patient treatment. There was no injury, death, or delay/change in treatment related to the reported issue and there was no report of harm for a patient, an operator or any other person.

  Patient problems: Insufficient Information

  MAUDE report 50870010 ↗
• InjuryApr 8, 2026High Test Results

  ON (B)(6) 2026, THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED HSTNI PATIENTS RESULTS ON THEIR ACCESS 2 INSTRUMENT (PART NUMBER C13252, SERIAL NUMBER (B)(6). THE CUSTOMER VERBALLY REPORTED THREE INSTANCES OF ERRONEOUSLY HIGH HSTNI PATIENT RESULTS: TWO AROUND (B)(6), AND ONE ON (B)(6). NO PATIENT- SPECIFIC DATA WAS SHARED. ONE PATIENT WAS TRANSPORTED FOR FURTHER COMPUTED TOMOGRAPHY SCAN. NO ADDITIONAL PATIENT IMPACTS OR ADVERSE TREATMENTS HAVE BEEN REPORTED. NO CALIBRATION DATA WAS PROVIDED. NO QUALITY CONTROLS (QC) INFORMATION WAS PROVIDED. NO ISSUES WITH SAMPLES INTEGRITY WERE REPORTED BY THE CUSTOMER. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING SAMPLES OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULTS. SYSTEM CHECK FAILED SEVERAL TIMES ON (B)(6) DUE TO WASHED MEAN, %CV [COEFFICIENT VARIATION] AND SUBSTRATE RATIO AND %CV. A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE.

  Patient problems: Insufficient Information

  MAUDE report 24817344 ↗