Data / Medical devices / United States / Beckman Coulter, Inc.
Beckman Coulter, Inc.: FDA-registered device maker in Miami, FL, United States, 69 510(k) clearances
Beckman Coulter, Inc. is registered with the FDA (registration 1061932) in Miami, FL, United States. It lists 47 device types. The FDA files 69 510(k) clearances under its listings, the newest dated July 5, 2024. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1061932
- FEI number
- 3000203293
- Address
- 11800 SW 147TH Ave., Miami, FL, United States, 33196
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- December 14, 1977
- Registered through
- 2026
- Brand names listed
- 395100 ICON Mono, 442831 PVT 2, 472055 PVT 5, 442830 PVT 3, 445865 SYNCHRON Systems Wash Concentrate II, 445967 SYNCHRON CX Systems Antifoam, 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2, 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3, 447060 IMMAGE Immunochemistry Systems Wash Solution, 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 5, 2024 | K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 16, 2020 | K193124 | Unicel DxH 800 Coulter Cellular Analysis System | GKZ | Substantially Equivalent | Beckman Coulter | accessdata.fda.gov |
| March 21, 2019 | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | PWD | Substantially Equivalent | Beckman Coulter | accessdata.fda.gov |
| March 1, 2019 | K181475 | DxH 520 Hematology Instrument | GKZ | Unknown | Beckman Coulter | accessdata.fda.gov |
| June 29, 2017 | DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | PWD | Unknown | Beckman Coulter | accessdata.fda.gov |
| June 23, 2017 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | OYE | Substantially Equivalent | Beckman Coulter | accessdata.fda.gov |
| November 29, 2016 | K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 10, 2015 | K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS | OYE | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 5, 2014 | K140911 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| September 18, 2013 | K130373 | NAVIOS FLOW CYTOMETER SYSTEM | OYE | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| July 15, 2013 | K130253 | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | PER | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 23, 2011 | K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | KQO | Substantially Equivalent | Iris International Inc., A Division of Iris Iris I | accessdata.fda.gov |
| February 3, 2009 | K082162 | COULTER BODY FLUID CONTROL | JPK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 21, 2009 | K081822 | COULTER 6C CELL CONTROL, MODELS 628027 & A59925 | JPK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| January 16, 2009 | K081641 | COULTER LIN-X LINEARITY CONTROL | JPK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 19, 2008 | K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| June 25, 2008 | K080812 | HEMOCCULT ICT | KHE | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 21, 2007 | K072640 | IRISPEC,CA/CB/CC | JJW | Substantially Equivalent | Iris Diagnostics | accessdata.fda.gov |
| August 17, 2005 | K051706 | IQ BODY FLUIDS CONTROL | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| March 23, 2005 | K050235 | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | GKL | Substantially Equivalent | Iris International, Inc. | accessdata.fda.gov |
| January 19, 2005 | K043215 | FLOWCARE PLG CD4 REAGENT | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| May 21, 2003 | K030828 | TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| April 17, 2003 | K030291 | COULTER ACT 5DIFF AUTOLOADER (AL) | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| March 4, 2003 | K030408 | CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A | GKZ | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| October 21, 2002 | K022774 | IQ 200 SYSTEM | LKM | Substantially Equivalent | Intl. Remote Imaging Systems | accessdata.fda.gov |
| May 23, 2002 | K020439 | STATUS HCG SERUM/URINE | JHI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| December 13, 2001 | K013842 | IMMUNO-TROL LOW CELLS | JPK | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
| December 26, 2000 | K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | Abx Diagnostics | accessdata.fda.gov |
| December 1, 2000 | K003534 | PENTRA 5D | JPK | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| October 15, 1999 | K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | Abx Diagnostics | accessdata.fda.gov |
| October 8, 1999 | K993065 | ACON COMBO PREGNANCY | JHI | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| April 13, 1999 | K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| April 1, 1999 | K990352 | COULTER AC T DIFF 2 ANALYZER | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| March 16, 1999 | K984216 | IMMUNO-TROL CONTROL CELLS | JPK | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| November 25, 1998 | K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | GTY | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 9, 1998 | K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| November 5, 1998 | K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| September 24, 1998 | K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| October 29, 1997 | K973634 | COULTER AC.T DIFF ANALYZER | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| February 4, 1997 | K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | KTN | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| January 6, 1997 | K962768 | CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| January 6, 1997 | K962305 | CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| December 23, 1996 | K964618 | CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| February 29, 1996 | K954688 | FLOW-COUNT COULTER FLUOROSPHERES | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| December 8, 1994 | K944751 | COULTER FLOW SET | JPK | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| July 6, 1993 | K926124 | CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| April 5, 1993 | K930119 | COULTER RETIC-C CELL CONTROL | JPK | Substantially Equivalent | Coulter Electronics, Inc. | accessdata.fda.gov |
| February 5, 1993 | K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| February 5, 1993 | K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| January 21, 1993 | K925344 | COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA | GKZ | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| December 29, 1992 | K921279 | CD4 CYTOSPHERES KIT | GKZ | Substantially Equivalent | Coulter Electronics, Inc. | accessdata.fda.gov |
| October 31, 1991 | K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| July 9, 1991 | K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE | KRX | Substantially Equivalent | R&D Systems, Inc. | accessdata.fda.gov |
| July 9, 1991 | K911793 | COULTERCLONE | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| March 2, 1990 | K893853 | COULTER CLONE T8 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| March 2, 1990 | K893852 | COULTER CLONE T4 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| February 12, 1990 | K894179 | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| December 29, 1989 | K895917 | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| September 13, 1989 | K894651 | COULTER POSITIVE CONTROL CELLS | GGL | Substantially Equivalent | Coulter Corp. | accessdata.fda.gov |
| August 15, 1989 | K884605 | COULTER CLONE MO2 | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| February 16, 1989 | K885028 | COULTER 5P CONTROL | GKZ | Substantially Equivalent | Coulter Electronics, Inc. | accessdata.fda.gov |
| February 3, 1989 | K884020 | COULTER CLONE B4 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| February 3, 1989 | K883753 | COULTER CLONE T1 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| December 27, 1988 | K884346 | CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| September 14, 1988 | K882557 | COULTER CLONE B1 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Immunology | accessdata.fda.gov |
| May 23, 1988 | K880499 | HEMOCCULT SENSITIVE TEST | KHE | Substantially Equivalent | Smithkline Diagnostics, Inc. | accessdata.fda.gov |
| March 9, 1988 | K875047 | COULTER CLONE T11 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | Coulter Electronics, Inc. | accessdata.fda.gov |
| April 4, 1984 | K840794 | S-CAL HEMATOLOGY CALIBRATOR | KRY | Substantially Equivalent | Coulter Electronics, Inc. | accessdata.fda.gov |
| December 22, 1983 | K832713 | IRI SPEC URINALYSIS CONTROL | JJW | Substantially Equivalent | Intl. Remote Imaging Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | 99832 | Class II | Ongoing | DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lami | accessdata.fda.gov |
| December 23, 2025 | 98207 | Class II | Ongoing | CellMek SPS Sample Preparation System, REF: C44603, with software | Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incor | accessdata.fda.gov |
| November 10, 2025 | 97992 | Class II | Ongoing | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cell | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. | accessdata.fda.gov |
| September 8, 2025 | 97531 | Class II | Ongoing | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or | accessdata.fda.gov |
| July 16, 2024 | 95159 | Class III | Ongoing | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF and, in vitro diagnostic device. | Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs and ) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case s | accessdata.fda.gov |
| December 19, 2023 | 93655 | Class II | Ongoing | Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results. | accessdata.fda.gov |
| May 31, 2023 | 92419 | Class II | Ongoing | COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells | Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. | accessdata.fda.gov |
| April 5, 2023 | 92056 | Class II | Ongoing | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and; b) iQ 200 Elite, Part Numbers C10683 and; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number, d) iQ200 Sprint, | Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated. | accessdata.fda.gov |
| November 18, 2022 | 91175 | Class II | Ongoing | BECKMAN COULTER IRISpec CA/CB/CC control, REF, For in vitro diagnostic use only. | Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN | accessdata.fda.gov |
| February 16, 2022 | 89655 | Class III | Ongoing | Beckman Coulter IRISpec CA/CB/CC control, Catalog #, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control. | IRISpec CA failures for glucose. | accessdata.fda.gov |
| June 23, 2021 | 88247 | Class II | Terminated | Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 | Software anomalies that may lead to the generation of erroneous results. | accessdata.fda.gov |
| February 17, 2020 | 85047 | Class II | Terminated | iChemVELOCITY Strips, Catalog | The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. | accessdata.fda.gov |
| October 7, 2019 | 84186 | Class II | Terminated | 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 de | When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment. | accessdata.fda.gov |
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Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.