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 Tissue Processor Recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH Due to Poorly processed and/or damaged biopsy tissue specimens on...

Date: April 10, 2024
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 Tissue Processor, REF 14048858005.

Quantity: 141 devices

Why Was This Recalled?

Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

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