Device recall
Z-3121-2017: Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is…
FDA device recall · Class II · Leica Biosystems Richmond Inc.
Key facts
| Recall number (Z-number) | Z-3121-2017 |
|---|---|
| Recall event | 78055 |
| Product | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in… |
| Product code | NJT |
| Recalling firm | Leica Biosystems Richmond Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2024 |
| FEI number | 1419341 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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