Device recall
Z-1299-2021: The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1299-2021 |
|---|---|
| Recall event | 87430 |
| Product | The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection. |
| Product code | LJZ |
| Recalling firm | Meridian Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2021 |
| 510(k) numbers | K934550 |
| FEI number | 1524213 |
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