Device recall
Z-1103-2007: american diagnostica inc. IgM Conjugate, 15mL; component of the american…
FDA device recall · Class II · Louisville Apl Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1103-2007 |
|---|---|
| Recall event | 38313 |
| Product | american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586. |
| Product code | MID |
| Recalling firm | Louisville Apl Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2007 |
| 510(k) numbers | K933588 |
| FEI number | 1000305932 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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