Device recall
Z-1307-2026: Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559…
FDA device recall · Class II · Fujirebio Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1307-2026 |
|---|---|
| Recall event | 98232 |
| Product | Product Name: Lumipulse -Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse -Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when… |
| 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