Device recall
Z-1060-2013: Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For…
FDA device recall · Class II · Polymedco, Inc
Key facts
| Recall number (Z-number) | Z-1060-2013 |
|---|---|
| Recall event | 64537 |
| Product | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces. |
| Product code | KHE |
| Recalling firm | Polymedco, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2016 |
| FEI number | 1000119795 |
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