DxI 9000 Access Immunoassay Analyzer C11137Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15099590732103), received between Mar 20, 2024 and Sep 8, 2026 — classified as 1 death, 1 injury, 1 malfunction.

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

17 FDA recall records name this device's identifier, 16 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 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-0216-2026 · Root cause: Software design · FDA record ↗

2. May 7, 2025Open, Classified

   Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

   Z-1996-2025 · Root cause: Software design · FDA record ↗

3. Apr 23, 2025Open, Classified

   A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

   Z-1926-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

4. Apr 23, 2025Open, Classified

   A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

   Z-1913-2025 · Root cause: Software design · FDA record ↗

5. Mar 27, 2025Open, Classified

   When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

   Z-1664-2025 · Root cause: Software design · FDA record ↗

6. Feb 6, 2025Open, Classified

   Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

   Z-1387-2025 · Root cause: Device Design · FDA record ↗

7. Feb 5, 2025Open, Classified

   the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

   Z-1388-2025 · Root cause: Process design · FDA record ↗

8. Nov 13, 2024Open, Classified

   The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

   Z-1326-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

9. Jul 12, 2024Open, Classified

   Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.

   Z-1529-2025 · Root cause: Device Design · FDA record ↗

10. Jun 4, 2024Open, Classified

    The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.

    Z-2414-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

11. May 22, 2024Open, Classified

    The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

    Z-2544-2024 · Root cause: Software design · FDA record ↗

12. May 22, 2024Open, Classified

    When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

    Z-2735-2024 · Root cause: Software design · FDA record ↗

13. Mar 5, 2024Open, Classified

    Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

    Z-1546-2024 · Root cause: Process control · FDA record ↗

14. Feb 29, 2024Open, Classified

    The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.

    Z-2237-2024 · Root cause: Under Investigation by firm · FDA record ↗

15. Jan 3, 2024Completed

    A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

    Z-1115-2025 · Root cause: Software design · FDA record ↗

16. Nov 21, 2023Open, Classified

    There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

    Z-0982-2024 · Root cause: Software design · FDA record ↗

17. Sep 12, 2023Open, Classified

    The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

    Z-0107-2024 · Root cause: Software design · 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 8, 2026Low Test Results

  On 17Aug2026, the customer reported non-reproducible false low hsTnI (Access High Sensitivity Troponin I, Reagent Part Number B52699 lot number 633714) results for eight (8) patients on their DxI 9000 analyzer (Part Number C11137 Serial Number (b)(6)). There was no report of death, injury, delay or change to patient treatment or diagnosis. There was no report of harm to patient, operator or any other person.The customer also reported grippers, wash collar and pick and place errors at the time of the event. There was fluid in the reagent storage. The Customer Technical Support explained it could be condensation. The customer provided the following non-repeatable erroneous low Access hsTnI results obtained for 8 patients (no unit and no date provided).- Patient 1 hsTnI result was <3 and repeated at 29.- Patient 2 hsTnI result was <3 and repeated at 17.2.- Patient 3 hsTnI result was <3 and repeated at 3822.- Patient 4 hsTnI result was <3 and repeated at 3384.7.- Patient 5 hsTnI result was <3 and repeated at 1510.7.- Patient 6 hsTnI result was <3 and repeated at 3349.0.- Patient 7 hsTnI result was <3 and repeated at 176.7. - Patient 8 hsTnI result was <3 and repeated at 5.2. System per

  Patient problems: Insufficient Information

  MAUDE report 50668887 ↗
• DeathMar 5, 2025Missing Test Results; Missing Test Results

  ON 06FEB2025 THE CUSTOMER REPORTED THAT PATIENT SAMPLES WERE QUEUING ON THE AUTOMATION LINE TRACK BEHIND DXA 5000 INSTRUMENT SERIAL NUMBER (S/N) (B)(6) CONNECTED TO DXI 9000 INSTRUMENT S/N (B)(6). FIELD SERVICE ENGINEER (FSE) NOTICED THAT NO HARDWARE ERROR MESSAGES WERE GENERATED ON THE DXI 9000 INSTRUMENT INDICATING THAT SAMPLES WERE NOT BEING ASPIRATED. THIS ISSUE CAUSED A DELAY IN REPORTING PATIENT RESULTS. THE CUSTOMER REPORTED A PATIENT DEATH WHILE WAITING FOR THE RESULTS BEING PROCESSED. UPON THE INITIAL REPORT OF THE EVENT, THE CUSTOMER DID NOT ALLEGE WHETHER THE DELAY IN OBTAINING THE RESULTS CONTRIBUTED TO THE PATIENT'S DEATH. THE HSTNI RESULT FOR THIS PATIENT SAMPLE WAS ELEVATED (236.26 NG/L) COMPARED WITH THE EXPECTED VALUES FOR OVERALL POPULATION (99TH PERCENTILE URL (95% CL): 17.5 PG/ML (12.6 - 20.7 PG/ML)). PER DISCUSSION BETWEEN FIELD APPLICATION SPECIALIST (FAS) AND THE CUSTOMER ON 11FEB2025, THE CUSTOMER STATED THE PHYSICIANS WERE NOT WAITING ONLY FOR THE HSTNI RESULT TO DETERMINE A DIAGNOSIS. THE CUSTOMER DID NOT CONFIRM WHETHER THE DELAY IN OBTAINING THE RESULT LED TO A DELAY IN DIAGNOSIS OR TREATMENT; THE CUSTOMER ALSO DID NOT PROVIDE THE PATIENT¿S DIAGNOSIS AND

  Patient problems: Insufficient Information

  MAUDE report 21527109 ↗
• InjuryMar 20, 2024No Device Output; No Device Output

  ON (B)(6) 2024, THE CUSTOMER REPORTED A DELAY IN TREATMENT DUE TO A DELAY IN OBTAINING A TSH (ACCESS TSH, PART NUMBER: C28643 AND LOT NUMBER NOT PROVIDED) FROM THE CUSTOMER'S DXI (DXI 9000, PART NUMBER: C11137 AND SERIAL NUMBER (SN): (B)(6) FOR ONE NEONATAL PATIENT. THE CUSTOMER REPORTED RUNNING THE PATIENT SAMPLE ON TWO OF THE CUSTOMER'S DXI 9000 INSTRUMENTS (ALTERNATE DXI 9000 INSTRUMENT SERIAL NUMBER: (B)(6) AND OBTAINING RESULTS FROM THE ALTERNATE INSTRUMENT BUT NOT FROM DXI SN: (B)(6). CUSTOMER STATED DXI 9000 SN: (B)(6) HAD DISPLAYED A "SWT" ERROR FOR THE TSH RESULT. THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT AND NO REPORT OF INJURY IN CONNECTION WITH THIS INCIDENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS ONSITE AT THE TIME OF THE INCIDENT. FSE STATED THAT THERE WERE TOO MANY SAMPLES GOING ONTO THE DXI 9000 AND THIS SAMPLE WAS NOT PRIORITIZED. AN INVESTIGATION IS ONGOING AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18945253 ↗