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.

126–150 of 334

  • ModerateFDA (Devices)·Z-3006-2020·2020-09-30

    Beckman Coulter Access Unconjugated Estriol Assay Systems Recalled for Interference

    Beckman Coulter is recalling Access Unconjugated Estriol assay systems because alkaline phosphatase interference may cause falsely elevated results.

    Product
    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2020·2020-06-10

    Beckman Coulter Access Free T4 Thyroxine Assay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Free T4 Thyroxine assays because biotin can cause significant result bias, potentially affecting patient care.

    Product
    Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and Uni
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2242-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Antibody II Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin Antibody II assays because biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel D
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2238-2020·2020-06-10

    Beckman Coulter Free T3 Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Free T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.

    Product
    Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2239-2020·2020-06-10

    Beckman Coulter Access Total T3 Assay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Total T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel D
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2240-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassay kits because biotin supplements can cause significant test result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and Un
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2241-2020·2020-06-10

    Beckman Coulter Access GI Monitor Cancer Antigen 19-9 Recalled for Biotin Interference

    Beckman Coulter is recalling Access GI Monitor Cancer Antigen 19-9 assays because biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i,
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2136-2020·2020-06-03

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent Due to Calibration Failures

    Beckman Coulter is recalling ISE Electrolyte Reference Reagent because low pH levels may cause calibration failures and false high patient results, potentially delaying treatment.

    Product
    ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1945-2020·2020-05-20

    Beckman Coulter iQ200 Urine Analyzer Recalled for Electrical Short Risk

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers due to a defect in the SATA power adapter cable that poses a risk of electrical short, charring, smoke, or flames.

    Product
    iQ200 Series Urine Microscopy Analyzer- All part numbers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1944-2020·2020-05-20

    Beckman Coulter iChem VELOCITY Urine Chemistry System Recalled for Fire Risk

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, smoke, or flames.

    Product
    iChem¿VELOCITY Urine Chemistry System-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2020·2020-05-06

    Beckman Coulter Recalls Barbiturates Reagent Due to Potential Test Inaccuracy

    Beckman Coulter is recalling SYNCHRON Systems Barbiturates Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative results.

    Product
    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbitura
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2020·2020-04-29

    Beckman Coulter Recalls Opiate 300 Ng Reagent Due to Cross-Reactivity Issues

    Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.

    Product
    Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1741-2020·2020-04-29

    Beckman Coulter Power Express Sample Processing System Recall for Biohazard Risk

    Beckman Coulter is recalling 291 Power Express Sample Processing System units due to a software design problem that causes sample splashing and potential biohazard exposure.

    Product
    Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1751-2020·2020-04-29

    Beckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity

    Beckman Coulter is recalling Synchron Opiate 2000 ng Reagent because cross-reactivity testing may not meet instructions for use, potentially causing false positive or negative urine test results.

    Product
    Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1674-2020·2020-04-15

    Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands

    Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.

    Product
    Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1673-2020·2020-04-15

    Beckman Coulter LabPro Data Management System Software Update Recall

    Beckman Coulter is recalling 177 LabPro Data Management Systems because a security update caused some computers to fail to restart, potentially delaying microbiology test results.

    Product
    LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1425-2020·2020-03-11

    Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk

    Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.

    Product
    Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1423-2020·2020-03-11

    Beckman Coulter Recalls Triglycerides Reagent Due to Acetaminophen Interference

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

    Product
    Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1422-2020·2020-03-11

    Beckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference

    Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.

    Product
    Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1426-2020·2020-03-11

    Beckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference

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

    Product
    Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
    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 pro
    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

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.