Device recall
Z-0162-2012: ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0162-2012 |
|---|---|
| Recall event | 60094 |
| Product | ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. The ARCHITECT Cyclosporine assay… |
| Product code | MKW |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2012 |
| 510(k) numbers | K080751 |
| FEI number | 1415939 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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