Device recall
Z-2588-2018: VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-2588-2018 |
|---|---|
| Recall event | 80087 |
| Product | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay) |
| Product code | JJE |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2025 |
| FEI number | 3002769706 |
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