Device product
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.
Z-1876-2016
Product summary
- Event
- Event 73802
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270 units
- Official record key
device-enforcement:Z-1876-2016
Official wording
Reason: 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.
Code information: 1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.
Distribution pattern: Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Derived failure modes
-
Unknown
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.