The Recall Desk

Manufacturer

Beckman Coulter, Inc.

334 recalls in our database name Beckman Coulter, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
334
Critical
0
Severe
6
Most recent
2026-08-26

Of the 334 recalls from Beckman Coulter, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

176–200 of 334

  • ModerateFDA (Devices)·Z-1643-2018·2018-05-16

    Beckman Coulter iChemVELOCITY Urine Chemistry System Recall for Incorrect Settings

    Beckman Coulter is recalling 2,225 iChemVELOCITY Urine Chemistry Systems because incorrect settings may cause false low results or incorrect color reporting.

    Product
    BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2018·2018-04-18

    Beckman Coulter AQUIOS CL Flow Cytometer System Recalled for Sample ID Errors

    Beckman Coulter is recalling 288 AQUIOS CL Flow Cytometer Systems because the single tube loader may process the same sample with two different IDs, potentially causing erroneous results.

    Product
    AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Under-Reporting Issue

    Beckman Coulter is recalling the iQ200 Series Urine Microscopy Analyzer because it may under-report casts when certain measurement settings are used. The issue could affect test results during initial setup or after settings are changed.

    Product
    BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1366-2018·2018-04-18

    Beckman Coulter iQ200 Urine Analyzer Recall for Barcode Reading Failures

    Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may fail to read dilution barcodes, causing erroneous results that could delay treatment.

    Product
    iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2018·2018-03-28

    Beckman Coulter AutoMate Systems Recalled for Premature Belt Failure

    Beckman Coulter is recalling AutoMate 1200, 1250, 2500, and 2550 systems due to premature belt failure that poses a remote risk of cross-contamination.

    Product
    AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1151-2018·2018-03-28

    Beckman Coulter AutoMate 2500 Chemistry Analyzer Recall for Sensor Defect

    Beckman Coulter is recalling AutoMate 2550 and 1250 chemistry analyzers because a misaligned sensor may fail to detect missing pipette tips, posing a remote risk of cross-contamination.

    Product
    AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0605-2018·2018-02-21

    Beckman Coulter Recalls Unpaired Lyophilized Chemistry Calibrator Lots

    Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.

    Product
    Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based p
    Category
    Medical Device
    Distribution
    44 states
  • LowFDA (Devices)·Z-0310-2018·2018-01-10

    Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk

    Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0308-2018·2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.

    Product
    Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0309-2018·2018-01-10

    Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk

    Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0237-2018·2017-12-20

    Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

    Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.

    Product
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0236-2018·2017-12-20

    Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

    Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

    Product
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0091-2018·2017-11-22

    Beckman Coulter AQUIOS CL Flow Cytometer Recalled for Sample Misidentification Risk

    Beckman Coulter is recalling 268 AQUIOS CL Flow Cytometers because the system may duplicate sample requests, leading to sample misidentification when connected to a Laboratory Information System.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagen
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0046-2018·2017-11-01

    Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error

    Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.

    Product
    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3135-2017·2017-09-27

    Beckman Coulter Recalls AQUIOS CL Flow Cytometer Due to Software Error

    Beckman Coulter is recalling AQUIOS CL Flow Cytometer systems because a software configuration error may cause the device to draw samples from the wrong tube, resulting in incorrect laboratory values.

    Product
    AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3118-2017·2017-09-20

    Beckman Coulter Recalls Sekisui Acetaminophen Reagent Due to Carryover

    Beckman Coulter is recalling 320 units of Sekisui Acetaminophen reagent because carryover from ACTH reagent may cause falsely elevated Lipase results on the AU 680 analyzer.

    Product
    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3114-2017·2017-09-13

    Beckman Coulter HmX Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling HmX CP and HmX AL analyzers because they may fail to flag or detect blasts in rare blood sample situations.

    Product
    Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2017·2017-09-13

    Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.

    Product
    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3101-2017·2017-09-06

    Beckman Coulter UniCel DxH Slidemaker Stainer Recall for Fitting Seal Defect

    Beckman Coulter is recalling 310 UniCel DxH Slidemaker Stainer units because a fitting may not completely seal after installation.

    Product
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2730-2017·2017-07-19

    Beckman Coulter Synchron AQUA CAL Level 1 Calibration Kits Recalled

    Beckman Coulter is recalling Synchron AQUA CAL Level 1 kits due to a sodium recovery shift that may affect system calibration.

    Product
    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2690-2017·2017-07-12

    Beckman Coulter PrepPlus 2 Recalled for Sample Preparation Imprecision

    Beckman Coulter is recalling 473 PrepPlus 2 units because they may produce imprecise absolute counts in the first tube of a flow cytometry run.

    Product
    Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Be
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2689-2017·2017-07-12

    Beckman Coulter PrepPlus Recalled for Imprecise Sample Preparation

    Beckman Coulter is recalling 43 PrepPlus systems because they may produce imprecise absolute counts in the first tube of a flow cytometry run.

    Product
    Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Beckman Coulter

company

Country
United States
Founded
1935
Parent company
Danaher Corporation

Official website

Source: Wikidata (Q479952), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.