Device recall
Z-1188-2024: In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF…
FDA device recall · Class III · Abbott Molecular, Inc.
Key facts
| Recall number (Z-number) | Z-1188-2024 |
|---|---|
| Recall event | 93902 |
| Product | In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020; |
| Product code | OYU |
| Recalling firm | Abbott Molecular, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 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