Device recall
Z-1306-2026: Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog…
FDA device recall · Class II · Fujirebio Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1306-2026 |
|---|---|
| Recall event | 98232 |
| Product | Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve… |
| Product code | SET |
| Recalling firm | Fujirebio Diagnostics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K242706 |
| FEI number | 2521625 |
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