Z-1710-2014 Class II Terminated
FDA device recall Z-1710-2014 was initiated by Leica Microsystems, Inc. on Jan 10, 2014 and is designated Class II. Reason for recall: Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity. The recall status is terminated (terminated Sep 5, 2017). Affected quantity: 145 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 11, 2014
- Initiation Date
- Jan 10, 2014
- Termination Date
- Sep 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145 units
Product Description
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
Reason for Recall
Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom
Code Information
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1710-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026