FDA Enforcement
Class II
Terminated
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.
Recall: Z-1876-2016
·
Reported June 8, 2016
Enforcement
- Recall Number
- Z-1876-2016
- Event ID
- 73802
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Leica Microsystems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 8, 2016
- Initiation Date
- April 5, 2016
- Classification Date
- June 1, 2016
- Termination Date
- November 30, 2017
- Address
- 1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States
Description
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.
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 Info
1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.
Distribution
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Quantity
270 units