Device recall
Z-1301-2026: Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog…
FDA device recall · Class II · Fujirebio Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1301-2026 |
|---|---|
| Recall event | 98232 |
| Product | Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay… |
| 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