Device recall
Z-1069-2007: IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated…
FDA device recall · Class II · Abbott Diagnostic International, Ltd.
Key facts
| Recall number (Z-number) | Z-1069-2007 |
|---|---|
| Recall event | 37920 |
| Product | IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent. |
| 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