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Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·March 5, 2025

Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·October 23, 2024

Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024

Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·June 12, 2024

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

FDA Enforcement
Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·May 1, 2024