LEICA BIOSYSTEMS NUSSLOCH GMBH: HistoCore PEGASUS Tissue Processors Recalled for Tissue Damage Risk

Agency Publication Date: December 20, 2023

Summary

Leica Biosystems is recalling 98 units of the HistoCore PEGASUS and HistoCore PEGASUS Plus automated tissue processors because of a software-related processing issue. An incorrect assignment of carryover values in created or edited protocols can result in poorly processed or damaged biopsy tissue specimens. These devices were distributed nationwide in the United States and are manufactured in Germany. Because these devices are used to process patient tissue samples for diagnostic purposes, damaged specimens could lead to delayed or incorrect diagnoses.

Risk

The defect involves an error in how the system calculates chemical carryover between processing steps, which can degrade or damage delicate patient tissue samples during laboratory processing. If tissue is damaged beyond repair, it may be impossible to perform necessary medical testing, potentially requiring patients to undergo repeat biopsies or resulting in diagnostic errors.

What You Should Do

Identify your device by checking the model name and serial number located on the device identification plate. This recall affects HistoCore PEGASUS (Automated Tissue Processors) with serial numbers in the range G0061 through G0701.
Review any custom or edited protocols on the device to ensure carryover values are correctly assigned according to the manufacturer's technical specifications.
Contact your healthcare provider or laboratory supervisor to determine if any previously processed tissue specimens were affected by this issue.
Contact Leica Biosystems directly at their German headquarters or through your local service representative for technical support and instructions on correcting the protocol settings.
Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.
For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Technical correction of protocol settings

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Model / REF:

HistoCore PEGASUS

HistoCore PEGASUS Plus

Lot Numbers:

Serial Number G0061

Serial Number G0062

Serial Number G0063

Serial Number G0701 (and all numbers in between)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93467

Status: Active

Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH

Sold By: Direct sales; Medical equipment distributors

Manufactured In: Germany

Units Affected: 98 devices

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify your device by checking the model name and serial number located on the device identification plate. This recall affects HistoCore PEGASUS (Automated Tissue Processors) with serial numbers in the range G0061 through G0701.

Review any custom or edited protocols on the device to ensure carryover values are correctly assigned according to the manufacturer's technical specifications.

Contact your healthcare provider or laboratory supervisor to determine if any previously processed tissue specimens were affected by this issue.

Contact Leica Biosystems directly at their German headquarters or through your local service representative for technical support and instructions on correcting the protocol settings.

Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.

For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.