Device recall
Z-1067-2007: AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG…
FDA device recall · Class II · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-1067-2007 |
|---|---|
| Recall event | 37920 |
| Product | AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use. |
| Product code | JHI |
| Recalling firm | Abbott Diagnostic International, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2012 |
| 510(k) numbers | K935673 |
| 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