Leica Microsystems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1877-2016)

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 CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

Product Classification:

Class II

Date Initiated: April 5, 2016
Date Posted: June 8, 2016
Recall Number: Z-1877-2016
Event ID: 73802
Reason for Recall:

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

Status: Terminated
Product Quantity: 90 Units
Code Information:

1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.

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