Device recall
Z-1499-2018: MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the…
FDA device recall · Class III · Diagnostic Hybrids, Inc.
Key facts
| Recall number (Z-number) | Z-1499-2018 |
|---|---|
| Recall event | 79642 |
| Product | MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum. |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 28, 2020 |
| FEI number | 1000122536 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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