Device recall
Z-0595-2007: Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ…
FDA device recall · Class III · Abbott Molecular
Key facts
| Recall number (Z-number) | Z-0595-2007 |
|---|---|
| Recall event | 37363 |
| Product | Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP… |
| Product code | MVU |
| Recalling firm | Abbott Molecular |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 17, 2008 |
| FEI number | 3005248192 |
At a glance
- None 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