FDA Device recall Z-3198-2018
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM…
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM… by Biocare Medical, citing immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3198-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-15 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biocare Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lot: 060617, Expiration: 2019/05 with a) Lot: 060117, and b) 053117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3198-2018%22
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