Official recall record

Flex Monoclonal Mouse Anti-Human CD20CY, Clone L26, Ready-To-Use (Dako Omnis)

What the authority reported

Weak staining has been observed in a few cases where GA604 was used to stain CLL/SLL tissue samples for CD20. This weak staining has not been observed in the majority of cases where GA604 was used to test CLL/SLL tissue. As a reminder, the diagnosis of CLL/SLL is made in the context of the histologic appearance by hematoxylin and eosin (H&E) staining, with the aid of a panel of immunohistochemical markers (routinely including other B cell markers such as PAX 5 or CD79), ancillary studies (e.g. flow cytometry on peripheral blood or bone marrow), and clinical information. Recall start date: July 28, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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