The Recall Desk

Manufacturer

Beckman Coulter Ireland, Inc.

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-01-28

Of the 3 recalls from Beckman Coulter Ireland, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–3 of 3

  • HighFDA (Devices)·Z-1135-2026·2026-01-28

    LDL cholesterol assays recalled over triglyceride interference causing biased results

    Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.

    Product
    The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0997-2026·2025-12-31

    Bicarbonate reagent recalled over falsely high results from LDH interference

    Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.

    Product
    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1815-2025·2025-06-04

    Apo B Reagent calibration error may produce inaccurate test results

    Beckman Coulter is recalling Apo B Reagent due to an erroneous value in the calibration sheet that could generate incorrect patient test results with positive bias up to 42%.

    Product
    Apo B Reagent, REF: OSR6143
    Category
    Medical Device
    Distribution
    Distributed nationwide