Device recall
Z-3185-2018: PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST…
FDA device recall · Class II · Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
Key facts
| Recall number (Z-number) | Z-3185-2018 |
|---|---|
| Recall event | 80724 |
| Product | PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and… |
| Product code | JHX |
| Recalling firm | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2019 |
| 510(k) numbers | K081360 |
| FEI number | 1000119795 |
At a glance
- 1–9 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