Device recall
Z-0099-2021: GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1…
FDA device recall · Class II · Gentian AS
Key facts
| Recall number (Z-number) | Z-0099-2021 |
|---|---|
| Recall event | 86465 |
| Product | GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1… |
| Product code | NDY |
| Recalling firm | Gentian AS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2022 |
| 510(k) numbers | K071388, K081875 |
| FEI number | 3006801241 |
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