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Leica Biosystems Nussloch GMBH FDA Recalls
10 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmwClass IIJan 30, 2025Firm became aware of software issues related to most recent |
| Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectClass IISep 4, 2024As part of our post market surveillance, we recognized that |
| Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,Class IISep 4, 2024As part of our post market surveillance, we recognized that |
| Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 149Class IISep 4, 2024As part of our post market surveillance, we recognized that |
| Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samplesClass IISep 4, 2024As part of our post market surveillance, we recognized that |
| Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1Class IISep 4, 2024As part of our post market surveillance, we recognized that |
| Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149Class IISep 4, 2024As part of our post market surveillance, we recognized that |
| Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.Class IIMay 10, 2024An issue with safe usage of the device was identified whereb |
| Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.Class IIApr 10, 2024Poorly processed and/or damaged biopsy tissue specimens on t |
| Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)Class IINov 20, 2023There is an issue regarding poorly processed and/or damaged |