Reported Sep 26, 2018 · Terminated
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44…
Biocare Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocare Medical, LLC · 60 Berry Dr · Pacheco, CA · 94553-5601
Is this the product you have?
URO-3 Triple Stain (CD44 + p53) with CK20Catalog #: PM370TSAA
- Package TypeBag
- which contains components
a) CD44 + p53Catalog #: PM373DSAA
- Package Type
Bottleand b) CK20Catalog #: PM062AA
- Package TypeBottle
- Product UsageURO-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
- Lot codes and dates
- Lot060617
- Expiration2019/05
- with a) Lot
060117and b) 053117
- Amount recalled
- 11
Where it was sold
Why it was recalled
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
This product could cause temporary or reversible health problems — stop using it.
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