Device recall
Z-0933-2022: Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes…
FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Recall number (Z-number) | Z-0933-2022 |
|---|---|
| Recall event | 89801 |
| Product | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD. |
| Product code | DKB |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 27, 2023 |
| FEI number | 1417592 |
At a glance
- None 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