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.
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Biocare Medical is recalling URO-3 Triple Stain (CD44 + p53) with CK20 kits because they contain mislabeled components that cause incorrect staining patterns. This could lead to inaccurate cancer diagnosis results if used in laboratory testing.
The kits contain mislabeled components that cause incorrect staining patterns. This could lead to inaccurate cancer diagnosis results if used in laboratory testing without proper quality control.
Pathologists and laboratory staff who use these kits for bladder cancer testing are affected. The risk is low as the issue is with labeling, not the product's safety.
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.
Look for the catalog number PM370TSAA on the bag packaging and verify the component lot numbers.
The kits contain mislabeled components that cause incorrect staining patterns, which could lead to inaccurate cancer diagnosis results.
Check for the catalog number PM370TSAA on the bag packaging and verify the component lot numbers (060617, 060117, or 053117).
The recall does not specify a remedy, so check with Biocare Medical for guidance.
We’ve drafted a message you can send Biocare Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3198-2018 — Biocare Medical Biocare Medical Hello, I own a Biocare Medical that is covered by recall Z-3198-2018 from Biocare Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
