Device recall
Z-2192-2020: Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556…
FDA device recall · Class II · Abbott Diagnostics Technologies AS
Key facts
| Recall number (Z-number) | Z-2192-2020 |
|---|---|
| Recall event | 85313 |
| Product | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics… |
| Product code | PDJ |
| Recalling firm | Abbott Diagnostics Technologies AS |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180296, K182988 |
| FEI number | 3003045237 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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