Device recall
Z-1308-2023: MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional…
FDA device recall · Class II · Quidel Corporation
Key facts
| Recall number (Z-number) | Z-1308-2023 |
|---|---|
| Recall event | 91772 |
| Product | MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above |
| Product code | DBA |
| Recalling firm | Quidel Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K872426 |
| 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