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.

LEICA BIOSYSTEMS NUSSLOCH GMBH Medical Device Recall: Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | SafeCheck