The Recall Desk

Manufacturer

Beckman Coulter, Inc.

334 recalls in our database name Beckman Coulter, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
334
Critical
0
Severe
6
Most recent
2026-08-26

Of the 334 recalls from Beckman Coulter, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) 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.

76–100 of 334

  • HighFDA (Devices)·Z-0787-2024·2024-01-31

    iQ Waste Well Adapter Recalled for Rust in Cannula Component

    Beckman Coulter recalls the iQ Waste Well Adapter due to rust in the cannula that may generate erroneous test results in laboratory diagnostic equipment.

    Product
    iQ Waste Well Adapter, Part Number: 700-3393
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0785-2024·2024-01-31

    Beckman Coulter iQ200 Analyzers Recalled for Potential Rust and Diagnostic Errors

    Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.

    Product
    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0784-2024·2024-01-31

    Beckman Coulter DxU Analyzers Recalled for Potential Rust-Related Diagnostic Errors

    Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.

    Product
    Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0100-2024·2023-10-18

    Access Thyroglobulin Calibrators Recalled for Inaccurate Test Results

    Beckman Coulter recalls Access Thyroglobulin Calibrators that cause approximately 11% decrease in patient test results. The recall affects about 5,980 units distributed worldwide except the US, Canada, and China.

    Product
    Access Thyroglobulin Calibrators
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0107-2024·2023-10-18

    Immunoassay Analyzer Software Error May Cause Sample Result Mix-up

    The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.

    Product
    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2023·2023-09-06

    Beckman Coulter IgA Diagnostic Reagent Recalled for Lipemic Test Interference

    Beckman Coulter is recalling approximately 12,850 units of IgA diagnostic reagent due to performance failures when testing lipemic blood samples, which could lead to inaccurate test results.

    Product
    Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2237-2023·2023-08-02

    Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results

    Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.

    Product
    Ringed DxI Reaction Vessels (RVs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2023·2023-07-19

    Medical Blood Cell Diluent Recalled for Out-of-Specification Parameters

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.

    Product
    COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2023·2023-07-05

    Access Hybritech p2PSA Reagent Recalled for Insufficient Blocking Reagent

    Beckman Coulter is recalling Access Hybritech p2PSA diagnostic reagent kits with insufficient blocking reagent concentration. Three lot numbers affecting 987 kits were distributed in the US and internationally.

    Product
    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1597-2023·2023-05-24

    Beckman Coulter Urine Analyzer Software Flag Display Issue Affects Carryover Detection

    Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.

    Product
    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1598-2023·2023-05-24

    Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

    Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

    Product
    DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1596-2023·2023-05-24

    Urine Microscopy Analyzer Software Display Defect May Prevent Contamination Detection

    Beckman Coulter's iQ200 Series urine analyzers may fail to display a flag indicating prior samples, potentially preventing detection of sample contamination from carryover events.

    Product
    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1607-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Potential Calibration Failures

    Beckman Coulter has recalled Bicarbonate reagent used in laboratory testing due to a potential decrease in calibration readings. The issue could result in calibration and quality control failures.

    Product
    Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2023·2023-05-24

    Urine Analysis Diagnostic Device Software Issue Prevents Carryover Detection

    Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.

    Product
    UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1606-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Worldwide Recall Due to Calibration Failure Potential

    Beckman Coulter is recalling Bicarbonate reagent (REF: OSR6137) worldwide due to potential decreases in calibration optical densities that could cause calibration and quality control failures in clinical laboratory tests.

    Product
    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1608-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk

    Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.

    Product
    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2023·2023-04-26

    Beckman Coulter Free T3 Reagent Test Kit Recalled for Falsely Elevated Results

    Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.

    Product
    Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2023·2023-03-22

    Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands

    Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.

    Product
    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2023·2023-01-11

    Beckman Coulter IRISpec glucose control false positive results with urine chemistry strips

    Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.

    Product
    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0269-2023·2022-11-30

    MicroScan autoSCAN-4 Instrument Recall Due to Incorrect Diffuser Plate

    Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.

    Product
    MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2022·2022-05-25

    Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating

    Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.

    Product
    MicroScan WalkAway-96 plus Instrument REF B1018-284
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2022·2022-05-25

    Medical analyzer instruments recalled for incorrect power connector rating

    Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.

    Product
    DxM 1096 MicroScan WalkAway Instrument REF B1018-496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2022·2022-05-25

    MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating

    Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2022·2022-05-25

    MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector

    Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.

    Product
    MicroScan WalkAway-40 plus Instrument REF B1018-283
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Beckman Coulter

company

Country
United States
Founded
1935
Parent company
Danaher Corporation

Official website

Source: Wikidata (Q479952), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.