Device recall
Z-1361-2019: ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1361-2019 |
|---|---|
| Recall event | 82590 |
| Product | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma. |
| Product code | JIT |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 20, 2019 |
| FEI number | 1415939 |
At a glance
- None 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