Device recall
Z-0765-06: VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in…
FDA device recall · Class I · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0765-06 |
|---|---|
| Recall event | 35020 |
| Product | VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders… |
| Product code | CDP |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 14, 2007 |
| 510(k) numbers | K964310 |
| 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