Device recall
Z-2078-2019: ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2078-2019 |
|---|---|
| Recall event | 83053 |
| Product | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. |
| Product code | JIT |
| 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