Agilent Technologies recalled 67 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from the potential for weak staining leading to false negative results in B-cell identification. Healthcare providers must cease use immediately and follow recall instructions.
Their is the potential for weak staining which may result in false negative CD20 identification.
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
The recalled product is the FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, with model number GA60461-2J. It is intended for immunohistochemistry use with the Dako Omnis instrument. The product was distributed nationwide across multiple states.
The product poses a high risk due to the potential for weak staining. This may lead to false negative results in identifying CD20, which is crucial for diagnosing B-cell neoplasms.
No specific incidents have been reported yet. The recall is proactive, aiming to prevent potential misdiagnosis in patients.
Stop using the affected product immediately. Contact Agilent Technologies Denmark ApS or your healthcare provider for further instructions.
For more information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2565-2025.
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