Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Leica HistoCore PEGASUS (PROCESSOR Recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH Due to There is an issue regarding poorly processed and/or...

Date: November 20, 2023
Company: LEICA BIOSYSTEMS NUSSLOCH GMBH
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LEICA BIOSYSTEMS NUSSLOCH GMBH directly.

Affected Products

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Quantity: 98 devices

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LEICA BIOSYSTEMS NUSSLOCH GMBH

LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report