Device recall
Z-1392-05: ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number…
FDA device recall · Class III · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-1392-05 |
|---|---|
| Recall event | 31466 |
| Product | ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA |
| Product code | JHI |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 25, 2006 |
| 510(k) numbers | K965116 |
| FEI number | 1415939 |
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