Device recall
Z-1334-2015: Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test…
FDA device recall · Class I · Lusys Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1334-2015 |
|---|---|
| Recall event | 70668 |
| Product | Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test. |
| Recalling firm | Lusys Laboratories, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 31, 2017 |
| FEI number | 3004473533 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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