Device recall
Z-0624-06: In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100…
FDA device recall · Class II · Abbott Health Products, Inc.
Key facts
| Recall number (Z-number) | Z-0624-06 |
|---|---|
| Recall event | 32890 |
| Product | In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv… |
| Product code | MGU |
| Recalling firm | Abbott Health Products, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2012 |
| PMA numbers | P890025 |
| FEI number | 2623532 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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