Dako recalls FLEX Monoclonal Mouse Anti-Human CD20cy (GA60461-2) 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 (GA60461-2) because it may cause false negative CD20 staining in cancer tissue tests. This could lead to incorrect cancer classification if used in immunohistochemistry.
The antibody may produce weak staining that fails to detect CD20 protein, which is critical for identifying B-cell cancers. This could lead to misclassification of tumors if the test shows a negative result when it should be positive.
Pathologists and lab technicians using this antibody for cancer tissue testing. Those with the lot numbers 41700704 or 41810164 are most at risk.
Check for lot numbers 41700704 or 41810164 on the product label. The product is sold under the brand name FLEX Monoclonal Mouse Anti-Human CD20cy (Dako Omnis) with catalog number GA60461-2.
Look for lot numbers 41700704 or 41810164 on the product label.
The recall is due to potential false negative CD20 staining, which could lead to incorrect cancer classification in immunohistochemistry tests.
Check the lot number on the product label. If it matches 41700704 or 41810164, contact Dako for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Dako to request your refund or repair — edit it as you like.
Subject: Recall Z-2563-2025 — Dako Dako Hello, I own a Dako that is covered by recall Z-2563-2025 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.
