BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1233-2025, Class II) was initiated on January 10, 2025. Its most recent 510(k) clearance was granted on August 2, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1233-2025 | Class II | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. | January 10, 2025 |