The Recall Desk

Manufacturer

Beckman Coulter Mishima K.K.

6 recalls in our database name Beckman Coulter Mishima K.K. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-03-18

Of the 6 recalls from Beckman Coulter Mishima K.K. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-1553-2026·2026-03-18

    Beckman Coulter AU5800 analyzer may stop analyzing after database errors

    Beckman Coulter is recalling Chemistry Analyzer AU5800 units because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2026·2026-03-18

    Beckman Coulter DxC 700 AU analyzer may stop analyzing after errors

    Beckman Coulter is recalling DxC 700 AU analyzers because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    DxC 700 AU, REF: B86444, B86446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2025·2025-06-11

    Beckman Coulter Sample Probes with Defective Tips Clinical Chemistry

    Beckman Coulter is recalling sample probes with defective tips used in clinical chemistry analyzers. The defective probes may dispense lower sample concentrations, potentially leading to false low test results and delayed diagnosis.

    Product
    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2025·2025-06-11

    Beckman Coulter Sample Probe Manufacturing Defect Recall

    Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.

    Product
    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2024·2024-08-28

    Clinical Chemistry Analyzer Software Issue Causes Delayed Results

    Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2024·2024-08-07

    Clinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results

    Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide