The Recall Desk

Manufacturer

Beckman Coulter, Inc.

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

What the numbers show

Total
338
Critical
0
Severe
13
Most recent
2026-10-21

Of the 338 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 13 (4%) 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.

201–225 of 338

  • 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
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2636-2017·2017-07-05

    Beckman Coulter Access Thyroglobulin Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassays because they are susceptible to biotin interference, which may affect test results.

    Product
    Access Thyroglobulin, A34085G, Catalog No. 33860
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2638-2017·2017-07-05

    Beckman Coulter Access System-GI Monitor Recalled for Biotin Interference

    Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.

    Product
    Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2157-2017·2017-05-31

    Beckman Coulter UniCel DxH 800 Recalled for Potential Data Errors

    Beckman Coulter is recalling UniCel DxH 800 systems because a software issue may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2017·2017-05-31

    Beckman Coulter UniCel DxH 600 Recall for Erroneous WBC Differential Results

    Beckman Coulter is recalling UniCel DxH 600 systems due to a software issue that may cause erroneous white blood cell differential results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2017·2017-05-31

    Beckman Coulter Recalls Microalbumin Reagent Due to Potential Out-of-Range Recovery

    Beckman Coulter is recalling Microalbumin Reagent Lot M609458 because it may recover outside the lower limit of the published insert range for Urine Protein Control Level 1.

    Product
    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2083-2017·2017-05-24

    Beckman Coulter Recalls Triglycerides Reagent Due to Interference

    Beckman Coulter is recalling Triglycerides Reagent because specific drugs can cause false low results.

    Product
    Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2084-2017·2017-05-24

    Beckman Coulter Recalls Salicylate Reagent Due to Drug Interference

    Beckman Coulter is recalling Salicylate Reagent (Catalog No. 378194) because specific drugs can cause false low results in salicylate testing.

    Product
    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2081-2017·2017-05-24

    Beckman Coulter Cholesterol Reagent Recalled for Potential Drug Interference

    Beckman Coulter is recalling Cholesterol Reagent (Catalog No. 467825) because specific drugs may cause false low results.

    Product
    Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2082-2017·2017-05-24

    Beckman Coulter Recalls HDL Cholesterol Reagent Due to Drug Interference

    Beckman Coulter is recalling HDL Cholesterol Reagent because specific drugs can cause false low results.

    Product
    HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2080-2017·2017-05-24

    Beckman Coulter Recalls Enzymatic Creatinine Reagent Due to Interference

    Beckman Coulter is recalling Enzymatic Creatinine Reagent because specific drugs can cause false low results. The recall affects 12,665 units distributed worldwide.

    Product
    Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2079-2017·2017-05-24

    Beckman Coulter Recalls Uric Acid Reagent Due to Drug Interference

    Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.

    Product
    Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2078-2017·2017-05-24

    Beckman Coulter Recalls Lactate Reagent Due to Interference from Specific Drugs

    Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.

    Product
    Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2035-2017·2017-05-10

    Beckman Coulter AQUIOS CL Flow Cytometer Software Export Defect Recall

    Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the software's Export feature incorrectly handles Tetra Combo CRD files.

    Product
    AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2017·2017-04-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests.

    Product
    Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1709-2017·2017-04-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect

    Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests in process.

    Product
    Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1704-2017·2017-04-12

    Beckman Coulter Recalls AU680 and AU5800 Rack ID Labels Due to Mismatch

    Beckman Coulter is recalling Rack ID Labels for AU680 and AU5800 analyzers because the displayed ID number and barcode do not match.

    Product
    Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1711-2017·2017-04-12

    Beckman Coulter Recalls UniCel DxC 600i SYNCHRON Access Clinical Systems

    Beckman Coulter is recalling specific UniCel DxC 600i SYNCHRON Access Clinical Systems because a circuit board defect can cause the device to stop running and cancel tests.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1384-2017·2017-03-08

    Beckman Coulter iChemVELOCITY Urine Chemistry System Recalled for Probe Misalignment

    Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because probe misalignment or bending can lead to delayed or incorrect patient results.

    Product
    iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2017·2017-01-25

    Beckman Coulter AutoMate 2500 Family Recalled for Operating System Update

    Beckman Coulter is recalling four AutoMate 2500 Family units in Maryland to update the PC image for Windows 10 compatibility.

    Product
    AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system…
    Category
    Medical Device
    Distribution
    1 state

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.