Device recall
Z-0040-2013: IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800…
FDA device recall · Class II · Immunodiagnostics Systems Ltd
Key facts
| Recall number (Z-number) | Z-0040-2013 |
|---|---|
| Recall event | 62968 |
| Product | IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic… |
| Product code | CIN |
| 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