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LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Recalled May 1, 2024 · FDA recall Z-0590-2024 · LEICA BIOSYSTEMS NUSSLOCH
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. · FDA Class II
Units
98 devices
Sold at
US, Nationwide
Description
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.
Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Manufacturer(s)
LEICA BIOSYSTEMS NUSSLOCH GMBH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →