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Health product recall

VENTANA® anti-Cd10 (SP67) Rabbit Monoclonal Primary Antibody

Last updated

Summary

Product
VENTANA® anti-Cd10 (SP67) Rabbit Monoclonal Primary Antibody
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
VENTANA® anti-Cd10 (SP67) Rabbit Monoclonal Primary Antibody K14266 J17541 K09880 M00669 K06239 K26461 J11853 J25047 J04613 K00982 J302286 K19784 790-4506

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies

Ventana Medical Systems Inc

1910 E Innovation Park Drive, Tucson, Arizona, United States, 85755

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75867

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