Device recall
Z-0163-2016: ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0163-2016 |
|---|---|
| Recall event | 72154 |
| Product | ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology. |
| Product code | JJE |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2016 |
| 510(k) numbers | K980367 |
| FEI number | 1628664 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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