Recall Z-3198-2018— Biocare Medical, LLC

Class II FDA medical device recall by Biocare Medical, LLC, initiated 2018-03-15, terminated 2020-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components..

Recalling firm

Biocare Medical, LLC

Classification

Class II

Status

Terminated

Initiated

2018-03-15

Terminated

2020-04-22

Firm location

Pacheco, CA, United States

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