Z-1876-2016 Class II Terminated
FDA device recall Z-1876-2016 was initiated by Leica Microsystems, Inc. on Apr 5, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Nov 30, 2017). Affected quantity: 270 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2016
- Initiation Date
- Apr 5, 2016
- Termination Date
- Nov 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270 units
Product 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 for Recall
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.
Distribution Pattern
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Code Information
1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1876-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026