Z-0590-2024Class II

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Name: Z-0590-2024 Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Creator: Leica Biosystems Nussloch Gmbh
Published: 2023-11-20
License: https://open.fda.gov/license/

Leica Biosystems Nussloch GmbH / initiated 2023-11-20 / Open, Classified

FDA source

LEICA BIOSYSTEMS NUSSLOCH GMBH began a recall of Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) on 2023-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0590-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2023-12-20
Recalling firm: Leica Biosystems Nussloch GmbH
Product: Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Product code: IEO Processor, Tissue, Automated
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.
FDA root cause: Other
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.
Quantity in commerce: 98 devices
Distribution: US, Nationwide
Product codes and lots: All devices with serial number: G0061-G0701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0590-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0590-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2023-12-19

Product code IEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)