Device recall
Z-3198-2018: URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type…
FDA device recall · Class II · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-3198-2018 |
|---|---|
| Recall event | 80407 |
| 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 CK20 is a cocktail of… |
| Product code | NJT |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2020 |
| FEI number | 3004140393 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database