Device recall
Z-1700-2016: 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1700-2016 |
|---|---|
| Recall event | 73441 |
| Product | 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of… |
| Product code | DHA |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2018 |
| 510(k) numbers | K063720 |
| 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