FDANovember 20, 2023device
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.
What to do
FDA enforcement status: Ongoing
Brands named
leica biosystems nusslochleicaleica biosystems
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.2025-04-02
- FDABrand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.012025-01-30
- FDALeica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples2024-09-04
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