Device recall
Z-1671-2020: ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-1671-2020 |
|---|---|
| Recall event | 84995 |
| Product | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the… |
| Product code | JJE |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 2, 2021 |
| 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