Device recall
Z-1834-2020: VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA device recall · Class III · Ortho Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1834-2020 |
|---|---|
| Recall event | 85298 |
| Product | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 |
| Product code | KLI |
| Recalling firm | Ortho Clinical Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 26, 2022 |
| 510(k) numbers | K160495 |
| FEI number | 1000136573 |
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