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.

251–275 of 334

  • ModerateFDA (Devices)·Z-0562-2016·2016-01-06

    Beckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives

    Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panels because they may produce falsely negative results for Staphylococcus aureus quality control tests.

    Product
    MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, so
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2016·2015-12-23

    Beckman Coulter Recalls DxH Slidemaker Stainer Software Due to ID Errors

    Beckman Coulter is recalling specific software versions for the DxH 600 and 800 Slidemaker Stainer systems because they allow the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2016·2015-12-23

    Beckman Coulter Recalls DxH 800 and DxH 600 Software Versions

    Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the systems allow multiple orders to share the same specimen ID with different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical labora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2016·2015-12-23

    Beckman Coulter Recalls DxH 800 and 600 Hematology Analyzer Software

    Beckman Coulter is recalling specific software versions for its DxH 800 and DxH 600 hematology analyzers because the software allows the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2016·2015-11-18

    Beckman Coulter Recalls Access CEA Assay Reagent Packs for Filling Errors

    Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.

    Product
    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.

    Product
    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2016·2015-10-14

    Beckman Coulter Recalls Access Free T3 Reagent Kits Due to Filling Errors

    Beckman Coulter is recalling Access Free T3 Reagent Kits because they were filled incorrectly and contain insufficient reagents.

    Product
    Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus Panels Due to Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation, leading to false resistant results.

    Product
    MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2015·2015-09-30

    Beckman Coulter MicroScan LabPro Software Recall for Manual Editing Error

    Beckman Coulter is recalling MicroScan LabPro software versions 1.0 to 4.11 because it incorrectly allows manual editing of carbohydrate substrates during specific manual readings.

    Product
    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2480-2015·2015-09-09

    Beckman Coulter Recalls LH Series Diluent Due to Cuvette Compromise Risk

    Beckman Coulter is recalling LH Series Diluent because it may eventually compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.

    Product
    COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2481-2015·2015-09-09

    Beckman Coulter Recalls Isoton 4 Diluent for Hematology Systems

    Beckman Coulter is recalling specific lots of Isoton 4 Diluent because they may compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.

    Product
    COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2733-2015·2015-09-09

    Beckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs

    Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.

    Product
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2015·2015-05-20

    Beckman Coulter Recalls DxH Diluent Due to Hemoglobin Chamber Compromise

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent because increased complaints indicate the product may compromise the hemoglobin chamber in certain blood analysis systems.

    Product
    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1524-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Pos Combo 33 Panels Due to Missing Desiccants

    Beckman Coulter is recalling 664 boxes of MicroScan Pos Combo 33 panels because some were packaged without desiccants, which may cause substrate deterioration.

    Product
    MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1528-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Performance Warning

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Neg Breakpoint Combo Panel Type 34

    Beckman Coulter is recalling 681 boxes of MicroScan Neg Breakpoint Combo Panel Type 34 due to reported panel degradation.

    Product
    MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1534-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Neg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1531-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Microbiology Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Microbiology Systems panels because a 2013 bulletin failed to mention a performance limitation for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Drie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1530-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Drie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1025-2015·2015-02-04

    Beckman Coulter Cholesterol Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Cholesterol Assay kits because N-acetyl cysteine administration can cause falsely low results.

    Product
    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2015·2015-02-04

    Beckman Coulter Lactate Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.

    Product
    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2015·2015-02-04

    Beckman Coulter Lipase Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine can cause falsely low results.

    Product
    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
    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.