Device recall
Z-0728-2007: ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0728-2007 |
|---|---|
| Recall event | 37446 |
| Product | ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500 |
| Product code | CHP |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 9, 2008 |
| FEI number | 1415939 |
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