Device recall
Z-0033-2022: Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605)…
FDA device recall · Class III · Sentinel CH SpA
Key facts
| Recall number (Z-number) | Z-0033-2022 |
|---|---|
| Recall event | 88680 |
| Product | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer. |
| Product code | JIS |
| Recalling firm | Sentinel CH SpA |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 24, 2023 |
| FEI number | 3000303338 |
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