Device recall
Z-0784-2019: Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche…
FDA device recall · Class II · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-0784-2019 |
|---|---|
| Recall event | 81823 |
| Product | Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The… |
| Product code | LOL |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2020 |
| 510(k) numbers | K093955 |
| FEI number | 1823260 |
At a glance
- 1–9 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