Device recall
Z-1707-2015: VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique…
FDA device recall · Class III · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-1707-2015 |
|---|---|
| Recall event | 71176 |
| Product | VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode… |
| Product code | CDP |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 13, 2017 |
| 510(k) numbers | K964310 |
| FEI number | 3007111389 |
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