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FDAFDA · Food and drugs·Recall number Z-3198-2018

URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. 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. The URO-3 Triple Stain is an adjunct immunohistochemistry test to assist a qualified pathologist in differentiating urothelial reactive atypia from CIS (carcinoma in situ) in suspected bladder lesions. The URO-3 staining pattern will be used as supporting data along with morphological and patient history context for the qualified pathologist to render a diagnosis.

Published September 26, 2018 · Recall initiated: March 15, 2018

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

Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Biocare Medical, LLC
Distributor
Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
Lot
Lot: 060617, Expiration: 2019/05 with a) Lot: 060117, and b) 053117
Risk classification
Class II
Area (FDA)
device
Country
United States

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