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

Agency Publication Date: June 4, 2024

Summary

Leica Biosystems is recalling 141 units of the HistoCore PEGASUS Tissue Processor because reagent levels can exceed maximum fill marks in the bottles or paraffin tanks. This defect can lead to poorly processed or permanently damaged biopsy tissue specimens, which may interfere with accurate medical diagnoses. The recall affects specific units with serial numbers ranging from G0061 to G0782 sold nationwide and in Canada. Leica Biosystems has initiated this voluntary recall to address the risk of specimen loss or diagnostic delay.

Risk

If reagents or paraffin overflow their designated fill levels, the device may fail to correctly process patient tissue samples. This can result in the loss of critical biopsy specimens or incorrect test results, potentially leading to delayed or improper medical treatment for patients.

What You Should Do

Identify if your device is affected by checking the serial number on your Leica HistoCore PEGASUS Tissue Processor (REF 14048858005). Affected serial numbers include: G0061 through G0154, G0156 through G0530, G0532 through G0779, G0781, and G0782.
Verify the UDI-DI number 04049188216397 on the device labeling to confirm it matches the recalled product.
Ensure that reagent bottles and paraffin tanks are not filled beyond the maximum fill level marks indicated on the hardware.
Contact Leica Biosystems Nussloch GmbH or your local Leica representative for further technical instructions and to discuss potential corrective actions for your specific device.
Contact your healthcare provider or laboratory supervisor if you believe tissue specimens processed on these devices may have been compromised.
Call the FDA's medical device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

Other Action

Manufacturer notification and technical guidance

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

Affected Products

Product: Leica HistoCore PEGASUS Tissue Processor, REF 14048858005

Model / REF:

14048858005

UDI-DI 04049188216397

Lot Numbers:

G0061 - G0154

G0156 - G0530

G0532 - G0779

G0781

G0782

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94470

Status: Active

Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH

Sold By: Leica Biosystems; Government distribution

Manufactured In: Germany

Units Affected: 141 devices

Distributed To: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

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

What You Should Do

Identify if your device is affected by checking the serial number on your Leica HistoCore PEGASUS Tissue Processor (REF 14048858005). Affected serial numbers include: G0061 through G0154, G0156 through G0530, G0532 through G0779, G0781, and G0782.

Verify the UDI-DI number 04049188216397 on the device labeling to confirm it matches the recalled product.

Ensure that reagent bottles and paraffin tanks are not filled beyond the maximum fill level marks indicated on the hardware.

Contact Leica Biosystems Nussloch GmbH or your local Leica representative for further technical instructions and to discuss potential corrective actions for your specific device.

Contact your healthcare provider or laboratory supervisor if you believe tissue specimens processed on these devices may have been compromised.

Call the FDA's medical device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.