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U.S. Department of Health and Human Services

Class 2 Device Recall URO3 Triple Stain (CD44 p52 CK20)

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  Class 2 Device Recall URO3 Triple Stain (CD44 p52 CK20) see related information
Date Initiated by Firm March 15, 2018
Create Date September 19, 2018
Recall Status1 Terminated 3 on April 22, 2020
Recall Number Z-3198-2018
Recall Event ID 80407
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
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.
Code Information Lot: 060617, Expiration: 2019/05 with a) Lot: 060117, and b) 053117
Recalling Firm/
Manufacturer		 Biocare Medical, LLC
60 Berry Dr
Pacheco CA 94553-5601
For Additional Information Contact
925-603-8002
Manufacturer Reason
for Recall		 Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 11
Distribution Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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