Leica Microsystems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1315-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 16, 2014

Date Posted: April 1, 2015

Recall Number: Z-1315-2015

Event ID: 70090

Reason for Recall:

The staining intensity decreases over the shelf life.

Status: Terminated

Product Quantity: 309 units

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated