Leica Microsystems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1710-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 10, 2014

Date Posted: June 11, 2014

Recall Number: Z-1710-2014

Event ID: 68090

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.

Status: Terminated

Product Quantity: 145 units

Code Information:

Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03

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

Voluntary or Mandated:

Voluntary: Firm initiated