Z-3198-2018Class II

URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains...

Name: Z-3198-2018 URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains...
Creator: Biocare Medical, LLC
Published: 2018-03-15
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2018-03-15 / Terminated / root cause: labeling and UDI

FDA source

Biocare Medical, LLC began a recall of URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package... on 2018-03-15. FDA classified it as Class II and gives the reason as "Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3198-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-15
Posted: 2018-09-19
Terminated: 2020-04-22
Recalling firm: Biocare Medical LLC
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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lot: 060617, Expiration: 2019/05 with a) Lot: 060117, and b) 053117

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3198-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3198-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-19

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)