Device recall
Z-0637-2012: ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed…
FDA device recall · Class II · Microgenics Corporation
Key facts
| Recall number (Z-number) | Z-0637-2012 |
|---|---|
| Recall event | 60756 |
| Product | ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack; |
| Product code | JJY |
| Recalling firm | Microgenics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 26, 2012 |
| 510(k) numbers | K061196 |
| 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