Device recall
Z-2169-2018: VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2169-2018 |
|---|---|
| Recall event | 80111 |
| Product | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii… |
| Product code | LGD |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 23, 2020 |
| 510(k) numbers | K101946 |
| FEI number | 1000611339 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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