Device recall
Z-1563-2013: Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems…
FDA device recall · Class II · Microgenics Corporation
Key facts
| Recall number (Z-number) | Z-1563-2013 |
|---|---|
| Recall event | 65187 |
| Product | Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory… |
| Product code | JJX |
| Recalling firm | Microgenics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2013 |
| 510(k) numbers | K031890 |
| FEI number | 3010939897 |
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