Beckman Coulter Mishima K.K.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1552-2026 | Class II | DxC 700 AU, REF: B86444, B86446 | January 30, 2026 |
| Z-1553-2026 | Class II | CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 | January 30, 2026 |
| Z-1907-2025 | Class II | Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount int | April 30, 2025 |
| Z-1908-2025 | Class II | Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount int | April 30, 2025 |
| Z-2691-2024 | Class II | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measur | July 10, 2024 |
| Z-2455-2024 | Class II | DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measur | June 5, 2024 |