Device recall
Z-0501-2015: MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in…
FDA device recall · Class II · Microgenics Corporation
Key facts
| Recall number (Z-number) | Z-0501-2015 |
|---|---|
| Recall event | 69670 |
| Product | MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations. |
| Product code | JJY |
| Recalling firm | Microgenics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2015 |
| 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