CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
URO-3 Triple Stain (CD44 + p53) with CK20 recalled by Biocare Medical
Biocare Medical is recalling URO-3 Triple Stain (CD44 + p53) with CK20, distributed nationwide in the US. The recall was initiated on 15 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3198-2018
- FDA event ID
- 80407
- Recalling firm
- Biocare Medical, Pacheco, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2018
- FDA classified
- 19 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Mar 2018 | Recall initiated by company | |
| 19 Sep 2018 | Classified by FDA | +188 days |
| 26 Sep 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
Questions about this recall
Why was it recalled?
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Which lots are affected?
Lot: 060617, Expiration: 2019/05 with a) Lot: 060117, and b) 053117
Where was it sold?
Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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