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Flex monoclonal mouse anti-human cd20cy, clone l26, ready-to-use (dako omnis)
Official notice
5 Sept 2025
Last checked
5 Sept 2025
An official Health Canada notice concerns Flex monoclonal mouse anti-human cd20cy, clone l26, ready-to-use (dako omnis). 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 Published 2025-09-05.
What to do now
Customers to be notified with instructions to follow.
Recall number
78022
Official notice
2025-09-05
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
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Company & contacts
Company & contacts
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Brand: Gap, Flex Monoclonal Mouse Anti-human Cd20cy Clone L26 Ready-to-use.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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