Device recall
Z-2079-2019: ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2079-2019 |
|---|---|
| Recall event | 83053 |
| Product | ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic… |
| Product code | JJX |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K060964 |
| FEI number | 1415939 |
At a glance
- 1–9 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