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
March 11, 2020FDAEnzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx …Z-1422-2020
March 11, 2020FDATriglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UD…Z-1423-2020
February 5, 2020FDAiChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B755…Z-0913-2020
December 4, 2019FDAUniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II)…Z-0516-2020
May 29, 2019FDAUniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B683…Z-1382-2019
May 29, 2019FDAUniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: No…Z-1383-2019
January 10, 2018FDAAccess 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used fo…Z-0308-2018
December 20, 2017FDAUniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzerZ-0236-2018
December 20, 2017FDAUniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 …Z-0237-2018
November 22, 2017FDAAQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman…Z-0091-2018
September 27, 2017FDAAQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an…Z-3135-2017
September 20, 2017FDASekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on …Z-3118-2017
September 13, 2017FDACoulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer i…Z-3114-2017
July 19, 2017FDABeckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for th…Z-2730-2017
July 12, 2017FDACoulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a micro…Z-2689-2017
July 5, 2017FDAAccess System-GI Monitor (CA19-9), A83873D, Catalog No. 387687Z-2638-2017
May 31, 2017FDAMicroalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when use…Z-2124-2017
May 24, 2017FDACholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determ…Z-2081-2017
May 24, 2017FDAAccess BR Monitor, Part No. 387620Z-2074-2017
May 24, 2017FDASalicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determ…Z-2084-2017
May 24, 2017FDAEnzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quan…Z-2080-2017
May 24, 2017FDAHDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative d…Z-2082-2017
May 10, 2017FDAAQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usag…Z-2035-2017
April 26, 2017FDAAccess Ferritin Calibrators, Part No. 33025, Ref No. B50136CZ-1833-2017
April 12, 2017FDAAccess 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The…Z-1710-2017

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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