Device recall
Z-1022-2013: Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is…
FDA device recall · Class II · Genetic Testing Institute,inc
Key facts
| Recall number (Z-number) | Z-1022-2013 |
|---|---|
| Recall event | 64501 |
| Product | Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). |
| Product code | LCO |
| Recalling firm | Genetic Testing Institute,inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2016 |
| 510(k) numbers | K053559 |
| FEI number | 2183608 |
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