Device recall
Z-1096-2007: ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1)…
FDA device recall · Class II · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-1096-2007 |
|---|---|
| Recall event | 37961 |
| Product | ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic. |
| Product code | LOM |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2011 |
| PMA numbers | P050051 |
| FEI number | 2623532 |
At a glance
- None 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