Leica Microsystems, Inc. recalls Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro sta

Recalled December 19, 2012 · FDA recall Z-0521-2013 · Leica Microsystems

Hazard

RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity. · FDA Class II

Units

322 vials

Sold at

Worldwide Distribution -- USA including Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin, and the country of Canada.

Description

RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.

Product

Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Manufacturer(s)

Leica Microsystems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →