Device recall
Z-0923-2011: K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1…
FDA device recall · Class III · Kamiya Biomedical Company, LLC
Key facts
| Recall number (Z-number) | Z-0923-2011 |
|---|---|
| Recall event | 50074 |
| Product | K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No… |
| Product code | MGA |
| Recalling firm | Kamiya Biomedical Company, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 20, 2011 |
| FEI number | 2084025 |
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