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.

101–125 of 334

  • HighFDA (Devices)·Z-1086-2022·2022-05-25

    Medical analyzer instruments recalled for incorrect power connector rating

    Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.

    Product
    DxM 1096 MicroScan WalkAway Instrument REF B1018-496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2022·2022-05-25

    MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector

    Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.

    Product
    MicroScan WalkAway-40 plus Instrument REF B1018-283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2022·2022-04-27

    Beckman Coulter IRISpec CA Control glucose measurement failures recalled

    Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.

    Product
    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2022·2022-03-09

    AU/DxC AU Magnesium Test Kits Recalled Due to Measurement Error in Lipemic Samples

    Beckman Coulter is recalling 181,776 AU/DxC AU Magnesium test kits because the test may give falsely elevated results in lipemic samples, potentially affecting clinical interpretation.

    Product
    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0399-2022·2021-12-29

    Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results

    Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.

    Product
    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0117-2022·2021-10-20

    Beckman Coulter Power Processor 3K Recalled for Missing Splash Guard

    Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.

    Product
    Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0032-2022·2021-10-13

    Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination

    Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.

    Product
    Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2602-2021·2021-10-06

    DxA 5000 Automation System Recalled Due to Sample Containment Defect

    Beckman Coulter is recalling 123 DxA 5000 automation systems due to a sample containment defect that may cause samples to drop, delaying patient treatment and risking biohazard exposure. Affected units were distributed to eleven states.

    Product
    DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2021·2021-09-29

    COVID-19 antibody test assay recalled due to insufficient validation evidence

    Beckman Coulter is recalling Access SARS-CoV-2 IgG test kits nationwide due to insufficient evidence in the FDA authorization submission. The test validation may be inadequate for accurate COVID-19 antibody detection.

    Product
    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2021·2021-09-01

    Laboratory Data Management Software Recalled for Potential Patient Result Errors

    Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.

    Product
    Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Test Recalled for False Positive Risk

    Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.

    Product
    ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2021·2021-08-18

    Beckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.

    Product
    ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2021·2021-08-18

    ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.

    Product
    ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2021·2021-08-18

    SARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results

    Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.

    Product
    Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2241-2021·2021-08-18

    Kaluza C Flow Cytometry Software Recalled for Potential Erroneous Results

    The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.

    Product
    Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2021·2021-06-30

    SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000

    Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.

    Product
    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1905-2021·2021-06-30

    SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions

    This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.

    Product
    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1670-2021·2021-06-02

    Beckman Coulter Access SARS-CoV-2 Antigen Recalled for False Negative Risk

    Beckman Coulter is recalling Access SARS-CoV-2 Antigen test kits because specimens stored in certain conditions may yield false negative results.

    Product
    Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2021·2021-04-14

    Beckman Coulter MicroScan WalkAway-40 Plus Reconditioned Instruments Recalled

    Beckman Coulter is recalling six reconditioned MicroScan WalkAway-40 Plus instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1373-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-96 plus Reconditioned Instruments

    Beckman Coulter is recalling nine MicroScan WalkAway-96 plus Reconditioned Instruments due to a shortened reagent draw straw that may cause reagent dispensing failures and organism misidentification.

    Product
    MicroScan WalkAway-96 plus Reconditioned Instrument
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1370-2021·2021-04-14

    Beckman Coulter Recalls MicroScan WalkAway-40 plus Instruments

    Beckman Coulter is recalling 16 MicroScan WalkAway-40 plus instruments because a shortened reagent straw may cause reagent dispensing failures, leading to organism misidentification or quality control failures.

    Product
    MicroScan WalkAway-40 plus Instrument
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0875-2021·2021-01-27

    Beckman Coulter Recalls SARS-CoV-2 IgG Quality Control Cards

    Beckman Coulter is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control cards due to a label error regarding standard deviation values.

    Product
    ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2021·2020-12-30

    Beckman Coulter MicroScan Pos MIC Panel Type 34 Recalled for QC Failure

    Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because a portion of the lot failed quality control, potentially causing false elevated daptomycin results.

    Product
    MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3028-2020·2020-10-07

    Beckman Coulter Recalls UIBC Reagent Lot 2690 Due to Erroneous Results

    Beckman Coulter is recalling 219 units of UIBC reagent lot 2690 because it produces erroneously high patient results at the low end of the linear range.

    Product
    UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.