Device recall
Z-1819-2024: VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free…
FDA device recall · Class II · QUIDELORTHO
Key facts
| Recall number (Z-number) | Z-1819-2024 |
|---|---|
| Recall event | 94436 |
| Product | VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820 |
| Product code | JIS |
| Recalling firm | QUIDELORTHO |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K994145 |
| FEI number | 3027243135 |
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