Device recall
Z-1520-2018: Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the…
FDA device recall · Class III · Diagnostic Hybrids, Inc.
Key facts
| Recall number (Z-number) | Z-1520-2018 |
|---|---|
| Recall event | 79595 |
| Product | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. |
| Product code | CEW |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 28, 2020 |
| 510(k) numbers | K974306 |
| FEI number | 1000122536 |
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