Device recall
Z-1426-2020: Total Bilirubin Reagent (TBIL 2 x 300) and (TBIL 2 x 400), Ref:442745 (300…
FDA device recall · Class II · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-1426-2020 |
|---|---|
| Recall event | 84832 |
| Product | Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge) |
| Product code | CIG |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2024 |
| 510(k) numbers | K902801 |
| 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