Device recall
Z-0903-2017: VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287…
FDA device recall · Class II · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-0903-2017 |
|---|---|
| Recall event | 75476 |
| Product | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) using… |
| Product code | CEW |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2018 |
| 510(k) numbers | K101921 |
| 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