Quick Facts at a Glance
- Recall Date
- August 11, 2025
- Hazard Level
- HIGH
- Brand
- Agilent Technologies
- 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
- Product type
- Monoclonal antibody reagent for immunohistochemistry
- Model numbers
- GA60461-2
- 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 is an immunohistochemistry antibody reagent used with the Dako Omnis instrument to label B-cell lineage cells for classification of B-cell neoplasms.
Why This Is Dangerous
Weak staining may cause false negative CD20 identification, potentially affecting diagnosis and subsequent treatment decisions.
Industry Context
This recall is not described as part of a broader industry safety pattern.
Real-World Impact
Hospitals and laboratories must stop using affected lots to avoid diagnostic errors and potential treatment delays.
Practical Guidance
How to identify if yours is affected
- Check inventory for GA60461-2 with lots 41700704 or 41810164.
- Verify UDI 05700572033042 on the labeling.
- Quarantine affected lots and follow manufacturer instructions.
- Initiate return/replacement per Agilent recall guidance.
Where to find product info
FDA recall page Z-2563-2025 and Agilent recall notices.
What timeline to expect
Remedies and replacements typically take 4-8 weeks, depending on stock and vendor processing.
If the manufacturer is unresponsive
- Escalate with institutional recall liaison.
- File a report with the FDA if the vendor remains unresponsive.
- Document all communications and dates.
How to prevent similar issues
- Institute inventory controls to flag recalled lots.
- Use validated antibodies compatible with the Dako Omnis system.
- Cross-check CD20 antibodies against recall notices before use.
Documentation advice
Keep copies of the recall notice, purchase orders, lot numbers, and all correspondence with the vendor.
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Product Details
Model/Catalog Number GA60461-2. Quantity: 4145 units. Lot numbers: 41700704 and 41810164. UDI: 05700572033042. Distribution: US nationwide. Sold at: Nationwide distribution to laboratories and medical facilities. Recall date: 2025-08-11. Status: ACTIVE. Manufacturer: Agilent Technologies Denmark ApS.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot numbers 41700704 and 41810164
- US nationwide distribution
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