Device recall
Z-2145-2016: VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784…
FDA device recall · Class III · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-2145-2016 |
|---|---|
| Recall event | 74346 |
| Product | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF… |
| Product code | LOJ |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 8, 2018 |
| 510(k) numbers | K983031 |
| FEI number | 3007111389 |
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