Device recall
Z-1425-2020: Direct Bilirubin Reagents (DBIL 2 x 200) and (DBIL 2 x 300), Ref:439715 (200…
FDA device recall · Class II · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-1425-2020 |
|---|---|
| Recall event | 84832 |
| Product | Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge) |
| Product code | CIG |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2024 |
| 510(k) numbers | K934068 |
| FEI number | 2050010 |
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