Z-1877-2016 Class II Terminated
FDA device recall Z-1877-2016 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 indicated are not stable up to the expiry date on the product labeling. The recall status is terminated (terminated Nov 30, 2017). Affected quantity: 90 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
- 90 Units
Product Description
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Reason for Recall
Testing of retained units indicated that Lot numbers of CDX2 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 Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1877-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026