Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0590-2024 — Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

U.S. FDA — Device Enforcement · Germany · 2023-11-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0590-2024
Date of alert
2023-11-20
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
LEICA BIOSYSTEMS NUSSLOCH GMBH
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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