Beckman Coulter Ireland, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1135-2026 | Class II | The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solub | December 8, 2025 |
| Z-0997-2026 | Class II | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reage | October 14, 2025 |
| Z-1815-2025 | Class III | Apo B Reagent, REF: OSR6143 | April 23, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K182651 | HbA1c Advanced | January 16, 2019 |
| K161508 | Ceruloplasmin | January 9, 2017 |
| K161297 | Beta-2-Microglobulin | June 7, 2016 |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | October 15, 2014 |
| K141388 | SYSTEM CALIBRATER | July 11, 2014 |
| K141374 | BICARBONATE CALIBRATOR | June 30, 2014 |
| K131546 | AU BICARBONATE REAGENT | October 9, 2013 |