Device recall
Z-0042-2013: IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box…
FDA device recall · Class II · Immunodiagnostics Systems Ltd
Key facts
| Recall number (Z-number) | Z-0042-2013 |
|---|---|
| Recall event | 62968 |
| Product | IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser)… |
| Product code | NEO |
| Recalling firm | Immunodiagnostics Systems Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2012 |
| FEI number | 3002485711 |
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