Device recall
Z-0947-2015: Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01…
FDA device recall · Class II · Phadia US Inc
Key facts
| Recall number (Z-number) | Z-0947-2015 |
|---|---|
| Recall event | 69872 |
| Product | Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple… |
| Product code | DHB |
| Recalling firm | Phadia US Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2015 |
| 510(k) numbers | K121156, K121463, K122197, K123275, K131738, K133404 |
| 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