Device recall
Z-0932-2021: Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako…
FDA device recall · Class III · Fujifilm Medical Systems U.S.A., Inc.
Key facts
| Recall number (Z-number) | Z-0932-2021 |
|---|---|
| Recall event | 87098 |
| Product | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma. |
| Product code | JIS |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 20, 2021 |
| 510(k) numbers | K001005 |
| FEI number | 1000513161 |
At a glance
- 1–9 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