Device recall
Z-1425-2012: Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the…
FDA device recall · Class II · Abbott Laboratories Inc.
Key facts
| Recall number (Z-number) | Z-1425-2012 |
|---|---|
| Recall event | 52748 |
| Product | Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. |
| Product code | CIG |
| Recalling firm | Abbott Laboratories Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2014 |
| 510(k) numbers | K022339 |
| FEI number | 2018433 |
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