Device recall
Z-0575-2020: Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics…
FDA device recall · Class II · Abbott GmBH & Co. KG
Key facts
| Recall number (Z-number) | Z-0575-2020 |
|---|---|
| Recall event | 84140 |
| Product | Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada |
| Product code | KHS |
| Recalling firm | Abbott GmBH & Co. KG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 14, 2021 |
| 510(k) numbers | K060295 |
| FEI number | 3002809144 |
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