Biocare Medical recalls URO-3 Triple Stain (CD44 + p53) with CK20 kits due to incorrect staining patterns from mislabeled components. Affected kits may lead to inaccurate cancer diagnosis results.
“Biocare URO-3 Triple Stain Kit: Incorrect Staining Pattern Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71706-biocare-uro-3-triple-stain-kit-incorrect-staining-pattern-risk. Based on FDA recall #Z-3198-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3198-2018%22&limit=1).
The FDA announced on March 15, 2018, that Biocare Medical, LLC voluntarily recalled URO-3 Triple Stain (CD44 + p53) with CK20 kits due to mislabeling causing incorrect staining patterns. The agency stated the recall involves 11 units distributed worldwide.
How to tell if you have it
Brand: Biocare Medical
Product: URO-3 Triple Stain (CD44 + p53) with CK20
The immunohistochemistry device kits were found to display incorrect staining patterns due to the mislabeling of two components. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Biocare Medical, LLC has had four other recalls since April 24, 2018. Other recent recalls include an intelliPATH HRP Detection Kit issue reported on September 25, 2024, and a 4plus Streptavidin HRP Label recall from October 10, 2019. Similar product recalls in the sector include a HydroMARK Breast Biopsy Marker recall on April 24, 2026, and a Bioporto ProNephro AKI Reagent Kit recall on May 18, 2026.
How to tell if you have this one
Check for the catalog number PM370TSAA on the bag packaging. The kit includes two components: a bottle labeled PM373DSAA and another labeled PM062AA. The lot numbers are 060617, 060117, or 053117.
Brand
Biocare Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Labels
Look for the catalog number PM370TSAA on the bag packaging and verify the component lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, New York.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3198-2018 (March 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3198-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.