Beckman Coulter recalls
Beckman Coulter appears in 334 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows:…
FDA Device · Class II · 2019-12-04 · Beckman Coulter - AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106
FDA Device · Class II · 2019-11-27 · Beckman Coulter - Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698
FDA Device · Class II · 2019-10-30 · Beckman Coulter - Beckman Coulter Lipase, REF OSR6130 and OSR6230
FDA Device · Class II · 2019-10-30 · Beckman Coulter - The Access Cortisol Reagent
FDA Device · Class II · 2019-10-09 · Beckman Coulter - Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual L…
FDA Device · Class II · 2019-07-24 · Beckman Coulter - iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial
FDA Device · Class II · 2019-07-10 · Beckman Coulter - UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322
FDA Device · Class I · 2019-05-29 · Beckman Coulter - UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858
FDA Device · Class I · 2019-05-29 · Beckman Coulter - UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized…
FDA Device · Class I · 2019-05-29 · Beckman Coulter - UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the…
FDA Device · Class II · 2019-04-10 · Beckman Coulter - The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line
FDA Device · Class II · 2019-04-10 · Beckman Coulter - 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro d…
FDA Device · Class I · 2018-11-28 · Beckman Coulter - COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
FDA Device · Class I · 2018-11-28 · Beckman Coulter - Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sort…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) in…
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc
FDA Device · Class III · 2018-11-07 · Beckman Coulter - Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc
FDA Device · Class III · 2018-11-07 · Beckman Coulter - MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification…
FDA Device · Class II · 2018-08-08 · Beckman Coulter - iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Ca…
FDA Device · Class II · 2018-05-30 · Beckman Coulter - BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan M…
FDA Device · Class II · 2018-05-23 · Beckman Coulter - iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagn…
FDA Device · Class II · 2018-05-23 · Beckman Coulter - BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-30…
FDA Device · Class II · 2018-05-16 · Beckman Coulter - iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 80…
FDA Device · Class II · 2018-04-18 · Beckman Coulter - BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320,…
FDA Device · Class II · 2018-04-18 · Beckman Coulter - AQUIOS CL Flow Cytometer System, Catalog #B30166
FDA Device · Class II · 2018-04-18 · Beckman Coulter - AutoMate 2550 "High Speed" Catalog Number ODL25255
FDA Device · Class II · 2018-03-28 · Beckman Coulter - AutoMate 1200 Catalog Number ODL25120
FDA Device · Class II · 2018-03-28 · Beckman Coulter - Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods…
FDA Device · Class II · 2018-02-21 · Beckman Coulter - Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative…
FDA Device · Class III · 2018-01-10 · Beckman Coulter - Access 2 Immunoassay System, Remanufactured, Catalog Number 386220
FDA Device · Class III · 2018-01-10 · Beckman Coulter - UniCel DxC 600i SYNCHRON Access Clinical Systems
FDA Device · Class III · 2018-01-10 · Beckman Coulter - UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
FDA Device · Class II · 2017-12-20 · Beckman Coulter - UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
FDA Device · Class II · 2017-12-20 · Beckman Coulter - UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is…
FDA Device · Class II · 2017-12-20 · Beckman Coulter - AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland
FDA Device · Class II · 2017-11-22 · Beckman Coulter - Power Processor 1K Stockyard
FDA Device · Class II · 2017-11-01 · Beckman Coulter - AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping
FDA Device · Class II · 2017-09-27 · Beckman Coulter - Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30
FDA Device · Class II · 2017-09-20 · Beckman Coulter - Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal s…
FDA Device · Class II · 2017-09-13 · Beckman Coulter - Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leuk…
FDA Device · Class II · 2017-09-13 · Beckman Coulter - UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of t…
FDA Device · Class II · 2017-09-06 · Beckman Coulter - Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Gluco…
FDA Device · Class II · 2017-07-19 · Beckman Coulter - Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation…
FDA Device · Class II · 2017-07-12 · Beckman Coulter - Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system desi…
FDA Device · Class II · 2017-07-12 · Beckman Coulter - Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
FDA Device · Class II · 2017-07-05 · Beckman Coulter - Access System-Free T4 Assay, B01902E, Catalog No. 33880
FDA Device · Class II · 2017-07-05 · Beckman Coulter