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Beckman Coulter Inc.

526 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 ( recall (Z-2242-2020)Beckman Coulter Inc.2020-06-02
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usag recall (Z-2136-2020)Beckman Coulter Inc.2020-05-28
iChemVELOCITY Urine Chemistry System- recall (Z-1944-2020)Beckman Coulter Inc.2020-05-09
iQ200 Series Urine Microscopy Analyzer- All part numbers recall (Z-1945-2020)Beckman Coulter Inc.2020-05-09
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in con recall (Z-1751-2020)Beckman Coulter Inc.2020-04-20
Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s recall (Z-1752-2020)Beckman Coulter Inc.2020-04-20
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 1509 recall (Z-1674-2020)Beckman Coulter Inc.2020-04-06
UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B6830 recall (Z-1382-2019)Beckman Coulter Inc.2019-05-23
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: T recall (Z-1383-2019)Beckman Coulter Inc.2019-05-23
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: Th recall (Z-1384-2019)Beckman Coulter Inc.2019-05-23
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation recall (Z-1077-2019)Beckman Coulter Inc.2019-03-30
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-config recall (Z-1078-2019)Beckman Coulter Inc.2019-03-30
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Softw recall (Z-0471-2019)Beckman Coulter Inc.2018-11-20
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software recall (Z-0472-2019)Beckman Coulter Inc.2018-11-20
BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% ly recall (Z-1804-2018)Beckman Coulter Inc.2018-10-02
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY recall (Z-1894-2018)Beckman Coulter Inc.2018-04-27
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the sys recall (Z-2730-2017)Beckman Coulter Inc2017-07-13
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C recall (Z-1833-2017)Beckman Coulter Inc.2017-04-17
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: T recall (Z-2035-2017)Beckman Coulter Inc.2017-04-17
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The recall (Z-1704-2017)Beckman Coulter Inc.2017-04-03
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI A recall (Z-1709-2017)Beckman Coulter Inc.2017-03-15
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Acce recall (Z-1710-2017)Beckman Coulter Inc.2017-03-15
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: Th recall (Z-1711-2017)Beckman Coulter Inc.2017-03-15
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, recall (Z-1384-2017)Beckman Coulter Inc.2017-03-01
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 recall (Z-1040-2017)Beckman Coulter Inc.2017-01-18
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B6830 recall (Z-1013-2017)Beckman Coulter Inc.2017-01-11
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 recall (Z-1014-2017)Beckman Coulter Inc.2017-01-11
MicroScan LabPro Data Management System. Intended to manage both microbial identification recall (Z-0768-2017)Beckman Coulter Inc.2016-12-15
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is us recall (Z-0648-2017)Beckman Coulter Inc.2016-11-21
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic fl recall (Z-2900-2016)Beckman Coulter Inc.2016-09-28
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B recall (Z-2732-2016)Beckman Coulter Inc.2016-09-02
AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chem recall (Z-2308-2016)Beckman Coulter Inc.2016-08-01
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chem recall (Z-2309-2016)Beckman Coulter Inc.2016-08-01
AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical che recall (Z-2310-2016)Beckman Coulter Inc.2016-08-01
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Sy recall (Z-2272-2016)Beckman Coulter Inc.2016-07-22
The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (che recall (Z-2247-2016)Beckman Coulter Inc.2016-07-20
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, recall (Z-2108-2016)Beckman Coulter Inc.2016-06-30
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029 recall (Z-0432-2016)Beckman Coulter Inc.2015-12-16
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 recall (Z-0433-2016)Beckman Coulter Inc.2015-12-16
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 recall (Z-0434-2016)Beckman Coulter Inc.2015-12-16
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic A recall (Z-0239-2016)Beckman Coulter Inc.2015-11-06
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panel recall (Z-0108-2016)Beckman Coulter Inc.2015-10-07
MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panel recall (Z-0109-2016)Beckman Coulter Inc.2015-10-07
Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle recall (Z-0110-2016)Beckman Coulter Inc.2015-10-07
MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 1071 recall (Z-2809-2015)Beckman Coulter Inc.2015-09-23
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitati recall (Z-2733-2015)Beckman Coulter Inc.2015-09-03
COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent pr recall (Z-2480-2015)Beckman Coulter Inc.2015-08-28
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze recall (Z-2481-2015)Beckman Coulter Inc.2015-08-28
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered recall (Z-1616-2015)Beckman Coulter Inc.2015-05-15
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 recall (Z-1524-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1528-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1529-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1530-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1531-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1532-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1533-2015)Beckman Coulter, Inc.2015-04-27
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imip recall (Z-1534-2015)Beckman Coulter, Inc.2015-04-27
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan N recall (Z-1522-2015)Beckman Coulter, Inc.2015-04-26
Beckman Coulter, Lipase Assay, Catalog No. OSR6X30 recall (Z-1023-2015)Beckman Coulter Inc.2015-01-28
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98 recall (Z-1024-2015)Beckman Coulter Inc.2015-01-28
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 recall (Z-1025-2015)Beckman Coulter Inc.2015-01-28
Beckman Coulter, Lactate Assay, Catalog No. OSR6X93 recall (Z-1026-2015)Beckman Coulter Inc.2015-01-28
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B1 recall (Z-0175-2015)Beckman Coulter Inc.2014-11-06
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Us recall (Z-0176-2015)Beckman Coulter Inc.2014-11-06
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the qua recall (Z-2687-2014)Beckman Coulter Inc.2014-09-23
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blo recall (Z-2651-2014)Beckman Coulter Inc.2014-09-16
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used recall (Z-1828-2014)Beckman Coulter Inc.2014-06-20
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagno recall (Z-1829-2014)Beckman Coulter Inc.2014-06-20
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that recall (Z-1830-2014)Beckman Coulter Inc.2014-06-20
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components tha recall (Z-1831-2014)Beckman Coulter Inc.2014-06-20
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Ac recall (Z-1737-2014)Beckman Coulter Inc.2014-06-09
Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnos recall (Z-0984-2014)Beckman Coulter Inc.2014-02-16
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in recall (Z-0985-2014)Beckman Coulter Inc.2014-02-16
Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro recall (Z-0519-2014)Beckman Coulter Inc.2013-12-16
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH recall (Z-0470-2014)Beckman Coulter Inc.2013-12-10
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 recall (Z-0471-2014)Beckman Coulter Inc.2013-12-10
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vi recall (Z-0291-2014)Beckman Coulter Inc.2013-11-14
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer recall (Z-0152-2014)Beckman Coulter Inc.2013-11-05
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automa recall (Z-0153-2014)Beckman Coulter Inc.2013-11-05
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 an recall (Z-0147-2014)Beckman Coulter Inc.2013-11-04
COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitat recall (Z-0113-2014)Beckman Coulter Inc.2013-11-01
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitat recall (Z-1997-2013)Beckman Coulter Inc.2013-08-22
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems) recall (Z-1951-2013)Beckman Coulter Inc.2013-08-10
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemi recall (Z-1873-2013)Beckman Coulter Inc.2013-08-02
AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions recall (Z-1834-2013)Beckman Coulter Inc.2013-07-31
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when use recall (Z-1613-2013)Beckman Coulter Inc.2013-06-27
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated an recall (Z-1430-2013)Beckman Coulter Inc.2013-05-29
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A9555 recall (Z-1400-2013)Beckman Coulter Inc.2013-05-24
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer recall (Z-1167-2013)Beckman Coulter Inc.2013-04-24
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are i recall (Z-1032-2013)Beckman Coulter Inc.2013-04-01
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro recall (Z-1033-2013)Beckman Coulter Inc.2013-04-01
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay System recall (Z-1034-2013)Beckman Coulter Inc.2013-04-01
UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Imm recall (Z-1035-2013)Beckman Coulter Inc.2013-04-01
Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitati recall (Z-0958-2013)Beckman Coulter Inc.2013-03-15
Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that m recall (Z-0913-2013)Beckman Coulter Inc.2013-03-06
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, recall (Z-0612-2013)Beckman Coulter Inc.2012-12-22
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 C recall (Z-0613-2013)Beckman Coulter Inc.2012-12-22
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quan recall (Z-0572-2013)Beckman Coulter Inc.2012-12-20
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The Un recall (Z-0345-2013)Beckman Coulter Inc.2012-11-19
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The Un recall (Z-0346-2013)Beckman Coulter Inc.2012-11-19
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Every clearance here is in the API, with alerts when new ones post.