Recall Z-3198-2018 ยท NJT Immunohistochemistry Reagents And Kits
Biocare Medical, LLC
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 qualitat
| Date | Mar 15, 2018 |
| Status | Terminated |
| Reason | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. |
| Root cause | Other |
| Action | On 03/15/2018, an initial email notification was sent to customers who had received the affected lot of product. Customers were asked to return unused product. On 03/29/2018, the firm mailed and emailed Urgent: Medical Device Recall Notification letter to customers. Customers were instructed to discontinue affected product use and distribution, complete and return the Return Response Form. Telephone number 800-799-9499 was provided. |
| Quantity | 11 |
| Distribution | Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.