Device recall
Z-1566-2008: AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay…
FDA device recall · Class II · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-1566-2008 |
|---|---|
| Recall event | 47203 |
| Product | AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma. |
| Product code | JIS |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2012 |
| 510(k) numbers | K952148 |
| FEI number | 2623532 |
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