Device recall
Z-1312-2018: ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP…
FDA device recall · Class II · Phadia US Inc
Key facts
| Recall number (Z-number) | Z-1312-2018 |
|---|---|
| Recall event | 79444 |
| Product | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. |
| Product code | DHB |
| Recalling firm | Phadia US Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2019 |
| 510(k) numbers | K051218 |
| FEI number | 3004973408 |
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