Device recall
Z-1497-2018: MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of…
FDA device recall · Class III · Diagnostic Hybrids, Inc.
Key facts
| Recall number (Z-number) | Z-1497-2018 |
|---|---|
| Recall event | 79642 |
| Product | MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may… |
| Product code | DAK |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 28, 2020 |
| 510(k) numbers | K862649 |
| FEI number | 1000122536 |
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