Device recall
Z-1496-2018: MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of…
FDA device recall · Class II · Diagnostic Hybrids, Inc.
Key facts
| Recall number (Z-number) | Z-1496-2018 |
|---|---|
| Recall event | 79629 |
| Product | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and… |
| Product code | DAK |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Recall class | Class II |
| 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