Device recall
Z-2671-2014: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative…
FDA device recall · Class II · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-2671-2014 |
|---|---|
| Recall event | 68974 |
| Product | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained… |
| Product code | MZO |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2017 |
| PMA numbers | P010021, P010021S024 |
| FEI number | 3007111389 |
At a glance
- None 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