Quick Facts at a Glance
- Recall Date
- August 11, 2025
- Hazard Level
- HIGH
- Brand
- Agilent Technologies Denmark ApS
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Agilent Technologies Denmark ApS
- Product type
- Immunohistochemistry Antibody
- Model numbers
- GA60461-2J
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 11, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Their is the potential for weak staining which may result in false negative CD20 identification.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Agilent Technologies Denmark ApS or your healthcare provider for instructions. Notification method: N/A
About This Product
This immunohistochemistry reagent is used to label CD20 on B cells in tissue samples. The L26 clone is a monoclonal antibody designed for use with Dako Omnis instruments to aid in classifying B-cell neoplasms.
Why This Is Dangerous
If staining is weak, CD20 may appear absent on slides. This can lead to misclassification and potential misdiagnosis in pathology workflows.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Labs may need to halt testing with the affected lot, implement alternative antibodies, and coordinate with leadership to prevent diagnostic delays while awaiting replacement.
Practical Guidance
How to identify if yours is affected
- Verify model GA60461-2J on the product packaging and vial label.
- Check lot number 41810156 on the vial and accompanying documentation.
- Confirm product was distributed in the United States and is within the recall scope.
Where to find product info
Identify serial numbers, lot numbers, and GTIN on the vial label and packaging. Manufacturer recall notices provide the official identifiers.
What timeline to expect
4-8 weeks for remedy processing and replacement or guidance, varies by facility and supplier.
If the manufacturer is unresponsive
- Escalate to institutional procurement or compliance departments.
- Document all attempts to contact the manufacturer and maintain a log.
How to prevent similar issues
- Implement recall monitoring for reagents and antibodies.
- Verify supplier recall status before using antibodies in diagnostic workflows.
- Adopt validated alternative antibodies and keep a list of approved substitutes.
Documentation advice
Keep the recall notice, product labels, lot numbers, purchase records, and all communications with the manufacturer as part of the incident file.
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Product Details
Model/ Catalog Number: GA60461-2J; Lot numbers: 41810156; GTIN: 41741883. Distribution: US nationwide in states including Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin. Sold at: Unknown. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model GA60461-2J; Lot 41810156
- US nationwide distribution listed by state
- High-hazard recall due to potential diagnostic inaccuracy
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