Z-1315-2015 Class II Terminated
FDA device recall Z-1315-2015 was initiated by Leica Microsystems, Inc. on Dec 16, 2014 and is designated Class II. Reason for recall: The staining intensity decreases over the shelf life. The recall status is terminated (terminated Sep 5, 2017). Affected quantity: 309 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 1, 2015
- Initiation Date
- Dec 16, 2014
- Termination Date
- Sep 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 309 units
Product Description
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
Reason for Recall
The staining intensity decreases over the shelf life.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom.
Code Information
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1315-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026