The Recall Desk

Manufacturer

Beckman Coulter, Inc.

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

What the numbers show

Total
338
Critical
0
Severe
13
Most recent
2026-10-21

Of the 338 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 13 (4%) 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.

151–175 of 338

  • HighFDA (Devices)·Z-1424-2020·2020-03-11

    Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0913-2020·2020-02-05

    Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.

    Product
    iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0914-2020·2020-02-05

    Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.

    Product
    iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0843-2020·2020-01-29

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Analyzers

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers because a software issue may prevent specific gravity flags, potentially leading to erroneous test results.

    Product
    iChem VELOCITY Urine Chemistry Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2020·2019-12-04

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk

    Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.

    Product
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2020·2019-11-27

    Beckman Coulter AutoMate Sorters Recalled for Sample Cross-Contamination Risk

    Beckman Coulter is recalling 83 AutoMate and Automate sorter systems due to a risk of sample cross-contamination when a connection time-out occurs with the Laboratory Information System.

    Product
    AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0210-2020·2019-10-30

    Beckman Coulter Lipase Recalled Due to Acetaminophen Interference

    Beckman Coulter is recalling Lipase assays because acetaminophen metabolites cause negative interference in overdose patients.

    Product
    Beckman Coulter Lipase, REF OSR6130 and OSR6230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2020·2019-10-30

    Beckman Coulter Uric Acid Assay Recalled Due to Interference

    Beckman Coulter is recalling Uric Acid assays because acetaminophen metabolites cause negative interference in overdose patients.

    Product
    Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2763-2019·2019-10-09

    Beckman Coulter Access Cortisol Reagent Recalled for Cross-Contamination

    Beckman Coulter is recalling Access Cortisol Reagent due to cross-contamination that may cause falsely decreased patient results.

    Product
    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2019·2019-07-24

    Beckman Coulter Recalls Kaluza C Flow Cytometry Software Due to Compatibility Issues

    Beckman Coulter is recalling Kaluza C Flow Cytometry Software because compatibility issues with Microsoft Windows updates render the software unusable, potentially delaying the reporting of results.

    Product
    Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1937-2019·2019-07-10

    Beckman Coulter iChem VELOCITY Urine Strips Recalled for False Positives

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Strips because increased sensitivity causes falsely elevated urobilinogen results.

    Product
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1383-2019·2019-05-29

    Beckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors

    Beckman Coulter is recalling 2,059 UniCel DxH 600 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1382-2019·2019-05-29

    Beckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling UniCel DxH 800 analyzers because sporadic platelet results may be erroneously elevated without system flags, potentially leaving thrombocytopenia unrecognized.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1384-2019·2019-05-29

    Beckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling 341 UniCel DxH 900 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1078-2019·2019-04-10

    Beckman Coulter Recalls UniCel DxC Clinical Systems Due to Software Error

    Beckman Coulter is recalling UniCel DxC clinical systems where a software scheduling error can cause sample mishandling and generate incorrect test results.

    Product
    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1077-2019·2019-04-10

    Beckman Coulter UniCel DxI 600 and 800 Systems Recalled for Software Error

    Beckman Coulter is recalling UniCel DxI 600 and 800 systems due to a software scheduling error that can cause incorrect immunoassay results.

    Product
    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0471-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect

    Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.

    Product
    1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0472-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect

    Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.

    Product
    COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0357-2019·2018-11-07

    Beckman Coulter iPAW Software Recall for Barcode Label Errors

    Beckman Coulter is recalling iPAW 4.2.1 software due to a defect that may generate incorrect barcode IDs when printing consecutive tube labels.

    Product
    Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the Sorting-Drive Client that is used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2019·2018-11-07

    Beckman Coulter Recalls iPAW Software Due to Barcode Labeling Errors

    Beckman Coulter is recalling iPAW software versions 4.2 and 4.2.1 because a specific barcode printing feature may generate incorrect IDs for tube labels.

    Product
    Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0356-2019·2018-11-07

    Beckman Coulter iPAW 4.2 Software Recalled for Barcode Labeling Errors

    Beckman Coulter is recalling the iPAW 4.2 User Kit software because a specific manual barcode printing function may generate incorrect IDs for sample tubes.

    Product
    Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0355-2019·2018-11-07

    Beckman Coulter Recalls Sorting-Drive Software Due to Barcode Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because the manual barcode printing function may generate incorrect IDs for sample tubes.

    Product
    Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0358-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recalled for Barcode Label Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect tube label IDs.

    Product
    Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0359-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recall for Barcode Printing Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect IDs for tube labels.

    Product
    Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0354-2019·2018-11-07

    Beckman Coulter Sorting-Drive 4.2 Software Recalled for Barcode Errors

    Beckman Coulter is recalling 25 units of Sorting-Drive 4.2 software due to a defect that may generate incorrect barcode IDs when printing consecutively numbered tube labels.

    Product
    Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and…
    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.