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FDAFDA · Food and drugs·Recall number Z-1698-2014

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

Published June 11, 2014 · Recall initiated: February 26, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Leica Microsystems, Inc.
Distributor
Nationwide Distribution including AZ, CA, FL, and NY.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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