FDA-Device2024-05-01Class II
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
LEICA BIOSYSTEMS NUSSLOCH GMBH
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.
Sold states
US, Nationwide
Affected count
98 devices
Manufactured in
Heidelberger Str. 17-19, N/A, Nussloch, N/A, Germany
Products
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2024Don't want to check this manually?
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