Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2018
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
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biocare Medical, LLC recalled URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which… - a moderate-severity action.
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which… was recalled by Biocare Medical, LLC in September 26, 2018. Reason: Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two compon…. Check the official notice for the remedy. Verify recall #Z-3198-2018 with the FDA Devices before acting.
The recall
Biocare Medical, LLC issued this moderate-severity FDA Devices recall-Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two compon….
- Moderate
- severity level
- 11 units
- affected scope
- Class II
- classification
- September 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3198-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3198-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on March 15, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Biocare Medical, LLC is listed as the recalling firm, operating out of Pacheco, CA. Federal records list the affected scope as 11.
The documented reason for this recall is: Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. Distribution data in the federal record shows the product reached: Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
11
Related Recalls
6
3 from same agency
Product 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.
Reason for recall
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3198-2018 |
| Date reported | September 26, 2018 |
| Date initiated | March 15, 2018 |
| Recalling firm | Biocare Medical, LLC |
| Firm location | Pacheco, CA |
| Affected scope | 11 |
| Distribution | Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3198-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biocare Medical, LLC. Units affected: 11.
Why was this product recalled? ▼
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3198-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3198-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.