URO-3 Triple Stain recall: Labeling Error
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA…
Why was URO-3 Triple Stain recalled?
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 060617, Expiration: 2019/05 with a) Lot: 060117, and b) 053117
- Product
- URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA…
- Recalling firm
- Biocare Medical, LLC
- Quantity
- 11
- Distribution
- Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)