Device recall
Z-2111-2011: Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part…
FDA device recall · Class II · Alere North Americal
Key facts
| Recall number (Z-number) | Z-2111-2011 |
|---|---|
| Recall event | 58407 |
| Product | Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part Number: 8117KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices |
| Product code | KHE |
| Recalling firm | Alere North Americal |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2013 |
| 510(k) numbers | K063693 |
| FEI number | 3006984151 |
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