PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 11, 2014 Initiated: February 26, 2014 #Z-1698-2014

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.

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.

Details

Recalling Firm
Leica Microsystems, Inc.
Units Affected
33 units
Distribution
Nationwide Distribution including AZ, CA, FL, and NY.
Location
Buffalo Grove, IL

Frequently Asked Questions

What product was recalled?
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.. Recalled by Leica Microsystems, Inc.. Units affected: 33 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1698-2014.