Beckman Coulter Inc.: 148 recalls on record

Recalls filed with 1 agency: FDA (148).

First recall on record: August 29, 2012. Most recent: August 26, 2026.

Risk classification: Class I: 2 · Class II: 141 · Class III: 5

Most recent recalls

DateAgencyProduct
April 12, 2017FDAUniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage…Z-1711-2017
April 12, 2017FDABeckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) …Z-1704-2017
April 12, 2017FDAAccess 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel …Z-1709-2017
March 8, 2017FDAiChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720,…Z-1384-2017
January 25, 2017FDAAutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL2525…Z-1040-2017
January 18, 2017FDADxH 600 Coulter Cellular Analysis System, Catalog No. B23858Z-1014-2017
December 21, 2016FDAMicroScan LabPro Data Management System. Intended to manage both microbial identificat…Z-0768-2017
September 7, 2016FDAUniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCe…Z-2692-2016
August 10, 2016FDAAU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical ch…Z-2309-2016
January 6, 2016FDAMicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positi…Z-0561-2016
December 23, 2015FDAUniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 77522…Z-0433-2016
September 9, 2015FDAAccess Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitat…Z-2733-2015
May 6, 2015FDAMicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Im…Z-1529-2015
May 6, 2015FDAMicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroSca…Z-1522-2015
February 4, 2015FDABeckman Coulter, Cholesterol Assay, Catalog No. OSR6X16Z-1025-2015
November 12, 2014FDAAccess 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B…Z-0175-2015
November 12, 2014FDAUniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for U…Z-0176-2015
October 1, 2014FDAUniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the qu…Z-2687-2014
September 24, 2014FDACoulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole…Z-2651-2014
July 2, 2014FDAUniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. …Z-1828-2014
July 2, 2014FDACoulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components …Z-1830-2014
July 2, 2014FDACoulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components…Z-1831-2014
July 2, 2014FDAUniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro di…Z-1829-2014
June 18, 2014FDAUltrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *T…Z-1737-2014
February 26, 2014FDAUniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is a…Z-0985-2014

Questions about this company

How many recalls does Beckman Coulter Inc. have?
Recalert has 148 U.S. recalls on record for Beckman Coulter Inc., published between August 29, 2012 and August 26, 2026.
Which agencies have handled Beckman Coulter Inc. recalls?
Beckman Coulter Inc. appears as the recalling firm in recalls from: FDA (148).

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