Device recall
Z-0173-2009: IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative…
FDA device recall · Class III · Immunodiagnostics Systems Inc
Key facts
| Recall number (Z-number) | Z-0173-2009 |
|---|---|
| Recall event | 49393 |
| Product | IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35. 9PD, UK… |
| Product code | MRG |
| Recalling firm | Immunodiagnostics Systems Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 13, 2012 |
| 510(k) numbers | K021163 |
| FEI number | 3004046329 |
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