Biocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling
Biocare Medical is recalling 11 URO-3 Triple Stain kits because two components were mislabeled, causing incorrect staining patterns in laboratory tests.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is mislabeling leading to incorrect staining patterns without any reported illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Biocare Medical, LLC is recalling 11 units of the URO-3 Triple Stain (CD44 + p53) with CK20, Catalog # PM370TSAA. The recall is due to mislabeling of two components within the kit, which resulted in the kits displaying incorrect staining patterns. The affected product is an immunohistochemistry device kit intended for laboratory use in the qualitative identification of CD44, p53, and CK20 proteins in formalin-fixed paraffin-embedded human tissues, primarily for bladder cancer characterization.
The affected lots are identified as Lot 060617 with an expiration date of 2019/05. The kits contain two specific components: CD44 + p53 (Catalog # PM373DSAA, Lot 060117) and CK20 (Catalog # PM062AA, Lot 053117). The distribution of these 11 units was worldwide, specifically within the United States in the states of New York and Florida, and in the countries of Morocco and Italy.
No illnesses or injuries have been reported in connection with this recall. The hazard is limited to the potential for incorrect diagnostic data due to the mislabeling. Users of the product should stop using the affected kits and contact Biocare Medical for further instructions or a return.
The recalled product
- 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
- Manufacturer
- Biocare Medical, LLC
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: 060617
- Expiration: 2019/05 with a) Lot: 060117
- and b) 053117
Distribution
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