Device recall
Z-2200-2021: Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic…
FDA device recall · Class III · Stanbio Laboratory, LP
Key facts
| Recall number (Z-number) | Z-2200-2021 |
|---|---|
| Recall event | 88323 |
| Product | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. |
| Product code | JIN |
| Recalling firm | Stanbio Laboratory, LP |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 29, 2022 |
| 510(k) numbers | K910108 |
| FEI number | 1616487 |
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