Device recall
Z-0640-04: ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization…
FDA device recall · Class III · Vysis
Key facts
| Recall number (Z-number) | Z-0640-04 |
|---|---|
| Recall event | 28384 |
| Product | ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens… |
| Product code | MMW |
| Recalling firm | Vysis |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 27, 2004 |
| 510(k) numbers | K011031, K013785 |
| FEI number | 1421461 |
At a glance
- 1–9 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