Device recall
Z-3303-2024: Healgen Series Reagent strips for Urinalysis are composed of several color pads…
FDA device recall · Class II · Healgen Scientific Llc
Key facts
| Recall number (Z-number) | Z-3303-2024 |
|---|---|
| Recall event | 95248 |
| Product | Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series… |
| Product code | JIR |
| Recalling firm | Healgen Scientific Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K111999 |
| FEI number | 3009238284 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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