Dako recalls FLEX Monoclonal Mouse Anti-Human CD20cy (GA60461-2CN) due to potential weak staining causing false negatives in CD20 identification. Affected lots: 41781549, 41762487, 41651581.
Their is the potential for weak staining which may result in false negative CD20 identification.
Dako is recalling a specific antibody product that may cause false negative CD20 results in lab tests. This could lead to incorrect cancer diagnoses if used in immunohistochemistry. The recall affects certain lots of the FLEX Monoclonal Mouse Anti-Human CD20cy antibody.
The antibody may produce weak staining, leading to false negative CD20 identification. This could result in misclassifying B-cell derived tumors. The risk is limited to laboratory use cases where precise CD20 detection is critical.
Lab technicians and pathologists using this antibody for cancer cell classification. Those with the specific lot numbers listed are most at risk.
Check the lot number on the product label: 41781549, 41762487, or 41651581. The product is labeled as FLEX Monoclonal Mouse Anti-Human CD20cy (Dako Omnis) with model GA60461-2CN.
Look for lot numbers 41781549, 41762487, or 41651581 on the product label.
FLEX Monoclonal Mouse Anti-Human CD20cy (Dako Omnis) with model GA60461-2CN.
It may cause weak staining leading to false negative CD20 identification in cancer cell tests.
No action is required beyond checking the lot number; the recall does not mandate stopping use.
We’ve drafted a message you can send Dako to request your refund or repair — edit it as you like.
Subject: Recall Z-2564-2025 — Dako Dako Hello, I own a Dako that is covered by recall Z-2564-2025 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.