Device recall
Z-1001-2015: PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits…
FDA device recall · Class II · Genetic Testing Institute,inc
Key facts
| Recall number (Z-number) | Z-1001-2015 |
|---|---|
| Recall event | 70012 |
| Product | PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4… |
| Product code | LCO |
| Recalling firm | Genetic Testing Institute,inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2015 |
| 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