Device recall
Z-0580-2009: ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device…
FDA device recall · Class II · Abbott Laboratories Inc.
Key facts
| Recall number (Z-number) | Z-0580-2009 |
|---|---|
| Recall event | 49597 |
| Product | ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to… |
| Product code | JIX |
| Recalling firm | Abbott Laboratories Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2012 |
| FEI number | 2018433 |
At a glance
- None 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