LEICA BIOSYSTEMS NUSSLOCH GMBH: Medical Device Recall in 2024 - (Recall #: Z-0590-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Product Classification:

Class II

Date Initiated: November 20, 2023

Date Posted: May 1, 2024

Recall Number: Z-0590-2024

Event ID: 93467

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.

Status: Ongoing

Product Quantity: 98 devices

Code Information:

All devices with serial number: G0061-G0701

Distribution Pattern:

US, Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated