Device recall
Z-2183-2014: VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320…
FDA device recall · Class II · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-2183-2014 |
|---|---|
| Recall event | 68890 |
| Product | VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen… |
| Product code | NIG |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 6, 2017 |
| FEI number | 3007111389 |
At a glance
- None 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