Agilent Technologies Denmark ApS recalled 4,145 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from potential weak staining that may lead to false negative CD20 identification. Healthcare providers and patients must stop using the product immediately.
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 FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, catalog number GA60461-2. It is intended for immunohistochemistry use with the Dako Omnis instrument. The product was distributed nationwide in the U.S.
The product has a potential for weak staining, which may result in false negative CD20 identification. This could hinder accurate diagnosis of B-cell neoplasms.
No specific incidents were reported. However, the potential for misdiagnosis poses a significant risk to patient care.
Stop using the product immediately. Follow the recall instructions provided by the manufacturer. Contact Agilent Technologies Denmark ApS or your healthcare provider for further instructions.
For more information, contact Agilent Technologies Denmark ApS. Visit the FDA recall page for updates: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2563-2025.
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