FDA recall Z-0590-2024

LEICA BIOSYSTEMS NUSSLOCH GMBH · Class II · device

Product

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

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

Key facts

Status: Ongoing
Initiation date: 2023-11-20
Report date: 2024-05-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Nussloch, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2024