Dako recalls FLEX Monoclonal Mouse Anti-Human CD20cy (GA60461-2J) due to potential false negative CD20 staining in immunohistochemistry. Affected lots may lead to incorrect cancer cell classification.
Their is the potential for weak staining which may result in false negative CD20 identification.
Dako is recalling FLEX Monoclonal Mouse Anti-Human CD20cy (GA60461-2J) because it may cause false negative CD20 staining in cancer tissue tests. This could lead to incorrect diagnosis of B-cell cancers if the test is not properly interpreted.
The antibody may produce weak staining that fails to detect CD20 proteins, leading to false negative results. This could cause incorrect classification of B-cell cancers if the test is interpreted without considering the potential for weak staining.
Pathologists and lab technicians using this antibody for cancer tissue testing. Those who rely on accurate CD20 identification for B-cell neoplasms are most at risk.
Check for lot numbers 41810156 or 41741883 on the product packaging. The product is labeled as FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis).
Look for lot numbers 41810156 or 41741883 on the packaging.
The product is FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) with model number GA60461-2J.
The product may cause false negative CD20 staining in immunohistochemistry, which could lead to incorrect cancer classification.
Check the lot number on the packaging. If it matches 41810156 or 41741883, contact Dako for guidance.
We’ve drafted a message you can send Dako to request your refund or repair — edit it as you like.
Subject: Recall Z-2565-2025 — Dako Dako Hello, I own a Dako that is covered by recall Z-2565-2025 from Dako. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
