Device recall
Z-1135-2021: S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended…
FDA device recall · Class III · Medline Industries Inc
Key facts
| Recall number (Z-number) | Z-1135-2021 |
|---|---|
| Recall event | 87184 |
| Product | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only. |
| Product code | JJX |
| Recalling firm | Medline Industries Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 9, 2023 |
| FEI number | 1417592 |
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