Device recall
Z-0034-2008: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic…
FDA device recall · Class III · Louisville Apl Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0034-2008 |
|---|---|
| Recall event | 39412 |
| Product | APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856). |
| Product code | MID |
| Recalling firm | Louisville Apl Diagnostics Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 24, 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