Class II

Medical Device Recall: Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

LEICA BIOSYSTEMS NUSSLOCH GMBH · November 20, 2023

Reason for Recall

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.

Distribution

US, Nationwide

States Affected

NATIONWIDE

Quantity Affected

98 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0590-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.