Device recall
Z-0379-2013: Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated…
FDA device recall · Class III · Microgenics Corporation
Key facts
| Recall number (Z-number) | Z-0379-2013 |
|---|---|
| Recall event | 62987 |
| Product | Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare… |
| Product code | JJY |
| Recalling firm | Microgenics Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 4, 2013 |
| 510(k) numbers | K110616 |
| 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