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Open, Classified

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

FDA Recall Z-0590-2024 · Posted 2023-12-20

Recalling FirmLEICA BIOSYSTEMS NUSSLOCH GMBH
Recall StatusOpen, Classified
Product CodeIEO
Date Initiated2023-11-20
Product Quantity98 devices

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.

Firm Action

Leica issued an URGENT Medical Device Recall notice to its consignees on 11/20/2023 via email. The notice explained the issue with the device and instructed the consignee to ensure the selection of the correct setting of the carryover value for al created or edited protocols and follow the instructions in the IFU.

Root Cause

Other

Distribution Pattern

US, Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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