Device recall
Z-1055-2012: ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an…
FDA device recall · Class III · Phadia US Inc
Key facts
| Recall number (Z-number) | Z-1055-2012 |
|---|---|
| Recall event | 60513 |
| Product | ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement of cockroach allergen IgE in human serum or plasma. |
| Product code | MVU |
| Recalling firm | Phadia US Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 4, 2013 |
| FEI number | 3004973408 |
At a glance
- None 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