Device recall
Z-0316-04: VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip…
FDA device recall · Class II · Biomerieux, Inc.
Key facts
| Recall number (Z-number) | Z-0316-04 |
|---|---|
| Recall event | 27577 |
| Product | VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The… |
| Product code | LSR |
| Recalling firm | Biomerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2004 |
| 510(k) numbers | K943812 |
| FEI number | 1039284 |
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