Health Canada — Medical Devices · Canada · 2024-07-25 · Type II
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Reported risk: Roche has received complaints regarding high background and off-target staining with certain lots of the VENTANA® anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody resulting in a risk of false positive results. Subsequent investigation identified that this high background and off-target staining can interfere with slide interpretation when using the recommended method sheet OptiView DAB IHC Detection Kit (product no.760-700 / 06396500001) / OptiView Amplification Kit (product no. 760-099 / 06396518001) and the ultraView Universal DAB Detection Kit (product no.760-500 i 05269806001) /Amplification Kit (product no. 760-080 / 05266114001) protocol. Recall start date: July 11, 2024
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