Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Beckman Coulter Ireland Inc appears in FDA device records in O CALLAGHANS MILLS Clare, IE. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Beckman Coulter Ireland Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Beckman Coulter Biomedical Divisionenforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Beckman Coulter Ireland Inc between 2013 and 2019. The busiest year on record is 2014, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K182651 | HbA1c Advanced | PDJ | Substantially Equivalent | |
| K161508 | Ceruloplasmin | DDB | Substantially Equivalent | |
| K161297 | Beta-2-Microglobulin | JZG | Substantially Equivalent | |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | DCF | Substantially Equivalent | |
| K141388 | SYSTEM CALIBRATER | JIX | Substantially Equivalent | |
| K141374 | BICARBONATE CALIBRATOR | JIT | Substantially Equivalent | |
| K131546 | AU BICARBONATE REAGENT | KHS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680746 | 1000206808 | Beckman Coulter Ireland Inc | LISMEEHAN, O CALLAGHANS MILLS Clare -- IE | 2026 | and 90 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DDBCeruloplasmin, Antigen, Antiserum, Control
- JHYColorimetric Method, Cpk Or Isoenzymes
- DIHColorimetry, Cholinesterase
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DLZEnzyme Immunoassay, Phenobarbital
- DBFFerritin, Antigen, Antiserum, Control
- GHHFibrin Split Products
- JHXFluorometric Method, Cpk Or Isoenzymes
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- DGCIge, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JFLPh Rate Measurement, Carbon-Dioxide
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control
- GGKProducts, Red-Cell Lysing Products
- CDDRadioassay, Vitamin B12
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDPRadioimmunoassay, Total Triiodothyronine
- CIWStarch-Dye Bound Polymer, Amylase
- DCNSystem, Test, C-Reactive Protein
- DHASystem, Test, Human Chorionic Gonadotropin
- DHRSystem, Test, Rheumatoid Factor
- DDDTransferrin, Rhodamine, Antigen, Antiserum, Control
- JHNTurbidimetric Method, Lipoproteins
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1135-2026 | 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 colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample. | Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL). | Class II | Open, Classified | |
| Z-0997-2026 | 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. | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. | Class II | Open, Classified | |
| Z-1815-2025 | Apo B Reagent, REF: OSR6143 | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited. | Class III | Open, Classified | |
| Z-0309-2024 | AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay. | The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain