Company ยท IE
Beckman Coulter Ireland, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2019. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
3recalls (2 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 |
| JHN | Turbidimetric Method, Lipoproteins | 1 |
| JIT | Calibrator, Secondary | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| PDJ | Hemoglobin A1c Test System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2019 | K182651 | HbA1c Advanced Beckman Coulter Ireland, Inc., IE | PDJ |
| Jan 9, 2017 | K161508 | Ceruloplasmin Beckman Coulter Ireland, Inc., IE | DDB |
| Jun 7, 2016 | K161297 | Beta-2-Microglobulin Beckman Coulter Ireland, Inc., IE | JZG |
| Oct 15, 2014 | K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator Beckman Coulter Ireland, Inc., IE | DCF |
| Jul 11, 2014 | K141388 | SYSTEM CALIBRATER Beckman Coulter Ireland, Inc. | JIX |
| Jun 30, 2014 | K141374 | BICARBONATE CALIBRATOR Beckman Coulter Ireland, Inc. | JIT |
| Oct 9, 2013 | K131546 | AU BICARBONATE REAGENT Beckman Coulter Ireland, Inc. | KHS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2026 | Beckman Coulter Ireland, Inc. 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 Open, Classified |
LBS | K040471 |
| Dec 23, 2025 | Beckman Coulter Ireland, Inc. 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 anal Open, Classified |
KHS | K131546 |
| May 23, 2025 | Beckman Coulter Ireland, Inc. Apo B Reagent, REF: OSR6143 Open, Classified |
JHN | K952466 |