FDA-Device2016-06-08Class II

Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

Leica Microsystems, Inc.
Hazard

Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.

Sold states
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Affected count
270 units
Manufactured in
1700 Leider Ln, N/A, Buffalo Grove, IL, United States
Products
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1876-2016

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