Device recall
Z-1303-2026: Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number…
FDA device recall · Class II · Fujirebio Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1303-2026 |
|---|---|
| Recall event | 98232 |
| Product | Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also… |
| 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