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.
Recall
- Recall Number
- Z-3198-2018
- Event Number
- 80407
- Firm
- Biocare Medical, LLC
- FEI Number
- 3004140393
- Product Code
- NJT
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 15, 2018
- Terminated
- April 22, 2020
- Address
- 60 Berry Dr, Pacheco, CA, 94553-5601
Description
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.
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
On 03/15/2018, an initial email notification was sent to customers who had received the affected lot of product. Customers were asked to return unused product. On 03/29/2018, the firm mailed and emailed Urgent: Medical Device Recall Notification letter to customers. Customers were instructed to discontinue affected product use and distribution, complete and return the Return Response Form. Telephone number 800-799-9499 was provided.
Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
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