Leica Microsystems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1698-2014)

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:

Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: February 26, 2014

Date Posted: June 11, 2014

Recall Number: Z-1698-2014

Event ID: 68065

Reason for Recall:

Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.

Status: Terminated

Product Quantity: 33 units

Code Information:

Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06

Distribution Pattern:

Nationwide Distribution including AZ, CA, FL, and NY.

Voluntary or Mandated:

Voluntary: Firm initiated