Device recall
Z-0697-2013: 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy…
FDA device recall · Class II · IDS (Immunodiagnostic Systems Ltd.)
Key facts
| Recall number (Z-number) | Z-0697-2013 |
|---|---|
| Recall event | 63840 |
| Product | 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with… |
| Product code | MRG |
| Recalling firm | IDS (Immunodiagnostic Systems Ltd.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2013 |
| 510(k) numbers | K021163 |
| FEI number | 6325 |
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