Z-1704-2016 Class II Terminated
FDA device recall Z-1704-2016 was initiated by Leica Microsystems, Inc. on Mar 22, 2016 and is designated Class II. Reason for recall: Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining. The recall status is terminated (terminated Nov 30, 2017). Affected quantity: 290 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 1, 2016
- Initiation Date
- Mar 22, 2016
- Termination Date
- Nov 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 290 units
Product Description
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
Reason for Recall
Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
Distribution Pattern
Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
Code Information
Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1704-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026