LEICA BIOSYSTEMS NUSSLOCH GMBH
FDA Regulatory Profile
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1247-2025 | Class II | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Sof | January 30, 2025 |
| Z-0088-2025 | Class II | Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) | September 4, 2024 |
| Z-0087-2025 | Class II | Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, | September 4, 2024 |
| Z-0085-2025 | Class II | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and section | September 4, 2024 |
| Z-0086-2025 | Class II | Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; f | September 4, 2024 |
| Z-0089-2025 | Class II | Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) | September 4, 2024 |
| Z-0090-2025 | Class II | Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, | September 4, 2024 |
| Z-2529-2024 | Class II | Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. | May 10, 2024 |
| Z-1947-2024 | Class II | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | April 10, 2024 |
| Z-0590-2024 | Class II | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | November 20, 2023 |