Device recall
Z-0416-06: Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific…
FDA device recall · Class III · Abbott Molecular
Key facts
| Recall number (Z-number) | Z-0416-06 |
|---|---|
| Recall event | 33825 |
| Product | Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations… |
| Product code | MAO |
| Recalling firm | Abbott Molecular |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 5, 2006 |
| FEI number | 3005248192 |
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