Leica Microsystems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1876-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

Product Classification:

Class II

Date Initiated: April 5, 2016

Date Posted: June 8, 2016

Recall Number: Z-1876-2016

Event ID: 73802

Reason for Recall:

Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.

Status: Terminated

Product Quantity: 270 units

Code Information:

1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.

Distribution Pattern:

Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.

Voluntary or Mandated:

Voluntary: Firm initiated